VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL)— 510(k) K260619
Substantially EquivalentBiomérieux, Inc.
FDA 510(k) clearance K260619 for VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL), Substantially Equivalent on 2026-09-28. Applicant: Biomérieux, Inc.. Device class: 2.
Summary
This is a VITEK 2 antimicrobial susceptibility test for cefepime against Streptococcus, with a reported range of 0.06 µg/mL or below to 4 µg/mL or above. It's filed under LON, short-incubation automated antimicrobial susceptibility test systems.
Class II, 21 CFR 866.1645. The Microbiology panel reviewed it as a Traditional 510(k).
Biomérieux, Inc. filed from Hazelwood, Missouri. Review took 215 days (February 25 to September 28, 2026).
Clearance details
- Applicant
- Biomérieux, Inc.
- Product code
- Product code LON
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
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More clearances from Biomérieux, Inc.
view allAdverse events under product code LON
product code LON- Malfunction
- 2,383
- Total
- 2,383
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.