Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories
Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories (Illinois): 510(k) cleared for Abbott Laboratories. Its amount of 89 is below the median of 138 (29th percentile). Dated 42 days ago, it serves as a historical benchmark. Score 36/100. 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: 89 · 29th percentile of 414 FDAPulse records · 0.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262156 |
| Device | Anti-HCV Next |
| Applicant | Abbott Laboratories |
| Specialty / panel | Microbiology |
| Product code | MZO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-26 |
| Decision date | 2026-09-23 |
| Review time (days) | 89 |
| Third-party review | No |
| Applicant location | Abbott Park, IL, US |
| amount percentile | 29th of 414 (median 138, 0.6x median) |
| Peer records CSV (57 IL 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: 2026-09-23
- 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: Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories's amount: 29th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 89-day review: this device is a strong predicate for similar products.
- Posted 42 days ago.
What is the FDAPulse record for Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories in Illinois?
Anti-HCV Next (K262156) by Abbott Laboratories was cleared on 2026-09-23 after 89 days of review.
How does Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories compare to other Illinois FDAPulse records?
Its amount of 89 is below the median (29th percentile); smaller records often move faster and face less competition. It is 42 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Anti-HCV Next (K262156) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Anti-HCV Next (K262156) | IL | 2026-09-23 |
| 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
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- Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics
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