bioMerieux, Inc. - FDA 510(k) Cleared Devices
Recent clearances: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System, VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance, VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
252
Total
251
Cleared
1
Denied
FDA 510(k) Regulatory Record - bioMerieux, Inc. Microbiology ✕
207 devices
Cleared
Jul 08, 2026
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
Microbiology
169d
Cleared
Apr 15, 2026
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
Microbiology
76d
Cleared
Aug 21, 2025
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
Microbiology
90d
Cleared
Mar 14, 2025
VITEK COMPACT PRO
Microbiology
451d
Cleared
Jun 12, 2024
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
Microbiology
265d
Cleared
Jun 07, 2024
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
Microbiology
260d
Cleared
Mar 11, 2024
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
Microbiology
84d
Cleared
Oct 23, 2023
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2...
Microbiology
90d
Cleared
Jul 05, 2023
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP...
Microbiology
98d
Cleared
Jun 26, 2023
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
Microbiology
325d
Cleared
Feb 16, 2023
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)
Microbiology
90d
Cleared
Feb 09, 2023
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
Microbiology
210d
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