Medical Device Manufacturer · US , Mchenry , IL

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

250 submissions · 249 cleared · Since 1983

250

Total

249

Cleared

Denied

bioMerieux, Inc. has 249 FDA 510(k) cleared microbiology devices. Based in Mchenry, US.

Latest FDA clearance: Aug 2025. 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.

FDA 510(k) cleared devices by bioMerieux, Inc.

250 devices

1-12 of 250

1 2 3 4

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

Cleared Feb 09, 2023

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

K222073 · LON

Microbiology · 210d

Cleared Feb 03, 2023

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

K223481 · LON

Microbiology · 77d

1 2 3 4

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

FDA 510(k) cleared devices by bioMerieux, Inc.

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