FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

175,218 clearances · 1976 to present · Updated monthly from FDA records

253 results for "bioMerieux, Inc."

1–24 of 253

Search insights Median review: 59d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology

Cleared Apr 15, 2026

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

VIDAS TBI (GFAP, UCH-L1)

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

K232954 · QOF

Biofire Diagnostics, LLC

Microbiology · 187d

Cleared Mar 11, 2024

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2...

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP...

VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)

VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP...

VITEK 2 AST-Gram Positive Cefoxitin Screen

VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)

VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS...

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)

VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole...

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)

K210287 · LON

bioMerieux, Inc.

Microbiology · 268d