VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.
VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc. (Missouri): 510(k) cleared for Biomérieux, Inc. Its amount of 215 is above the median of 138 (69th percentile). Dated 37 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 215 · 69th percentile of 414 FDAPulse records · 1.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related MO FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260619 |
| Device | VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) |
| Applicant | Biomérieux, Inc. |
| Specialty / panel | Microbiology |
| Product code | LON |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-25 |
| Decision date | 2026-09-28 |
| Review time (days) | 215 |
| Third-party review | No |
| Applicant location | Hazelwood, MO, US |
| amount percentile | 69th of 414 (median 138, 1.6x median) |
| Peer records CSV (4 MO records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (MO first): VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260 · Restrata (K261245) · Class II recall Z-3231-2026 · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc. and 4 Missouri peers
- Missouri FDAPulse records like this one: 4
- VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.'s amount: 69th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Missouri peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 215-day review, longer than typical.
- Posted 37 days ago.
What is the FDAPulse record for VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc. in Missouri?
VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619) by Biomérieux, Inc. was cleared on 2026-09-28 after 215 days of review.
How does VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc. compare to other Missouri FDAPulse records?
Its amount of 215 sits in the upper half (69th percentile) of 414 records; the median is 138. It is 37 days old, still within a typical 45-day follow-up window.
VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL) (K260619) | MO | 2026-09-28 |
| B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302) | DE | 2026-10-23 |
| Elecsys EBV EBNA IgG (K260221) | IN | 2026-10-02 |
| Elecsys EBV VCA IgG (K260232) | IN | 2026-10-02 |
Related records
- B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
- Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics
- Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics
- Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics
- VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.
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