DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC
DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC (Texas): 510(k) cleared for Nuclein, LLC. Its amount of 180 is above the median of 138 (63rd percentile). Dated 14 days ago, it is in the active follow-up window. Score 54/100. As of 2026-11-03, 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: 180 · 63th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related TX FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261347 |
| Device | DASH Flu A/B Test |
| Applicant | Nuclein, LLC |
| Specialty / panel | Microbiology |
| Product code | OCC |
| Device class | 2 |
| Clearance type | Dual Track |
| Decision | Substantially Equivalent |
| Received | 2026-04-24 |
| Decision date | 2026-10-21 |
| Review time (days) | 180 |
| Third-party review | No |
| Applicant location | Austin, TX, US |
| amount percentile | 63th of 414 (median 138, 1.3x median) |
| Peer records CSV (12 TX records) | 🔒 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: 2026-10-21
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC and 12 Texas peers
- Texas FDAPulse records like this one: 12
- DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC's amount: 63rd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Texas peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
54 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 180-day review, longer than typical.
- Posted 14 days ago.
What is the FDAPulse record for DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC in Texas?
DASH Flu A/B Test (K261347) by Nuclein, LLC was cleared on 2026-10-21 after 180 days of review.
How does DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC compare to other Texas FDAPulse records?
Its amount of 180 sits in the upper half (63th percentile) of 414 records; the median is 138. It is fresh: dated 14 days ago, inside the window where early outreach matters most.
DASH Flu A/B Test (K261347) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| DASH Flu A/B Test (K261347) | TX | 2026-10-21 |
| 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
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- Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc.
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- Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid
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