Medical Device Manufacturer · US , Mchenry , IL

bioMerieux, Inc.

250 submissions · 249 cleared · Since 1983
250
Total
249
Cleared
1
Denied

bioMerieux, Inc. — FDA 510(k) Submissions

bioMerieux, Inc. has submitted 250 FDA 510(k) premarket notifications since 1983, of which 249 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, Culture Media, Selective And Non-differential, Culture Media, Non-selective And Non-differential, System, Blood Culturing, Culture Media, Non-selective And Differential . Use the specialty filter in the sidebar to narrow results.

250 devices
1–25 of 250
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 ?g/mL)
K251579 · LON System, Test, Automated,... · Microbiology
Aug 2025 90d
VITEK COMPACT PRO
K234012 · LON System, Test, Automated,... · Microbiology
Mar 2025 451d
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 ?g/mL)
K232967 · NGZ Susceptibility Test... · Microbiology
Jun 2024 265d
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 ?g/mL)
K232963 · NGZ Susceptibility Test... · Microbiology
Jun 2024 260d
VIDAS TBI (GFAP, UCH-L1)
K240279 · QAT Brain Trauma Assessment Test · Immunology
May 2024 90d
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 ?g/mL)
K234000 · LON System, Test, Automated,... · Microbiology
Mar 2024 84d
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 ?g/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 ?g/mL), VITEK 2 Streptococcus Penicillin
K232201 · LON System, Test, Automated,... · Microbiology
Oct 2023 90d
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 ?g/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 ?g/mL), VITEK 2 AST-GP Daptomycin
K230864 · LON System, Test, Automated,... · Microbiology
Jul 2023 98d
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
K222378 · LON System, Test, Automated,... · Microbiology
Jun 2023 325d
VITEK? 2 AST-Gram Negative Plazomicin (=0.5 - =16 ?g/mL); VITEK? 2 AST-GN Plazomicin (=0.5 - =16 ?g/mL); VITEK? 2 AST-GN Plazomicin
K223478 · LON System, Test, Automated,... · Microbiology
Feb 2023 90d
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
K222073 · LON System, Test, Automated,... · Microbiology
Feb 2023 210d
VITEK? 2 Streptococcus Tetracycline (<=0.25 - >=16 ?g/mL)
K223481 · LON System, Test, Automated,... · Microbiology
Feb 2023 77d
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 ?g/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 ?g/mL), VITEK 2 AST-GP Moxifloxacin
K220803 · LON System, Test, Automated,... · Microbiology
Jan 2023 315d
VITEK 2 AST-Gram Positive Cefoxitin Screen
K220805 · LON System, Test, Automated,... · Microbiology
Oct 2022 209d
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 ?g/mL)
K212243 · LON System, Test, Automated,... · Microbiology
Aug 2022 385d
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 ?g/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 ?g/mL), VITEK 2 AST-YS Caspofungin
K213899 · LON System, Test, Automated,... · Microbiology
Jul 2022 210d
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 ?g/mL)
K213931 · LON System, Test, Automated,... · Microbiology
Jun 2022 169d
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 ?g/mL)
K214023 · LON System, Test, Automated,... · Microbiology
Apr 2022 113d
VITEK MS PRIME
K212461 · QBN Mass Spectrometry, Maldi... · Microbiology
Mar 2022 221d
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 ?g/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 ?g/mL), VITEK 2 AST-YS Fluconazole
K213241 · LON System, Test, Automated,... · Microbiology
Feb 2022 148d
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287 · LON System, Test, Automated,... · Microbiology
Oct 2021 268d
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396 · LON System, Test, Automated,... · Microbiology
Sep 2021 389d
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 ?g/mL)
K211630 · LON System, Test, Automated,... · Microbiology
Aug 2021 95d
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 ?g/mL)
K201675 · LON System, Test, Automated,... · Microbiology
Jul 2021 385d
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
K211136 · LON System, Test, Automated,... · Microbiology
Jun 2021 59d

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