# VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 48/100

| 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 |

## Why this score
- 215-day review, longer than typical.
- Posted 37 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260619). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.