Medical Device Manufacturer · US , Mchenry , IL

bioMerieux, Inc. - FDA 510(k) Cleared Devices

252 submissions · 251 cleared · Since 1983

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

Denied

bioMerieux, Inc. has 251 FDA 510(k) cleared microbiology devices. Based in Mchenry, US.

Latest FDA clearance: Jul 2026. Active since 1983.

Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

3 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

bioMerieux, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - bioMerieux, Inc.

252 devices

1-12 of 252

1 2 3 4

Cleared Jul 08, 2026

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

K260160 · SAN

Microbiology · 169d

Cleared Apr 15, 2026

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

K260282 · LON

Microbiology · 76d

Cleared Aug 21, 2025

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

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

K232967 · NGZ

Microbiology · 265d

Cleared Jun 07, 2024

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

K232963 · NGZ

Microbiology · 260d

Cleared May 01, 2024

VIDAS TBI (GFAP, UCH-L1)

K240279 · QAT

Immunology · 90d

Cleared Mar 11, 2024

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

K234000 · LON

Microbiology · 84d

Cleared Oct 23, 2023

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

K232201 · LON

Microbiology · 90d

Cleared Jul 05, 2023

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

K230864 · LON

Microbiology · 98d

Cleared Jun 26, 2023

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

K222378 · LON

Microbiology · 325d

Cleared Feb 16, 2023

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

K223478 · LON

Microbiology · 90d

1 2 3 4

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bioMerieux, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - bioMerieux, Inc.

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