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

1

Denied

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

30 devices

1-12 of 30

Cleared May 01, 2024

VIDAS TBI (GFAP, UCH-L1)

Immunology · 90d

Cleared Jun 22, 2009

VIDAS CA 15-3 ASSAY

Immunology · 487d

Cleared Apr 10, 2009

VIDAS CA 125 II ASSAY

Immunology · 407d

Cleared Oct 09, 2008

VIDAS CEA (S) ASSAY

Immunology · 258d

Cleared Sep 26, 2008

VIDAS AFP ASSAY

Immunology · 267d

Cleared Apr 24, 2001

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

Immunology · 57d

Cleared Feb 10, 1983

SALMONELLA-SHIGELLA AGAR

Immunology · 30d

Cleared Feb 10, 1983

BILE ESCULIN AZIDE AGAR

Immunology · 30d

Cleared Feb 10, 1983

Immunology · 30d

Cleared Feb 09, 1983

MUELLER HINTON W/50% SHEEP BLOOD

Immunology · 29d

Cleared Feb 09, 1983

Immunology · 29d

Cleared Feb 09, 1983

THAYER-MARTIN, MODIFIED

Immunology · 29d