Medical Device Manufacturer · US , Northridge , CA

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

14 submissions · 14 cleared · Since 1999

Recent clearances: BIOCHECK FERRITIN ELISA MODEL BC-1025, BIOCHECK IGE ELISA, MODEL BC-1035, BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027

14

Total

14

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Jun 16, 2004

BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114

Immunology · 161d

Cleared Sep 26, 2000

BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

Immunology · 180d

Cleared Sep 24, 1999

BIOCHECK FERRITIN ELISA MODEL BC-1025

Immunology · 58d

Cleared Sep 21, 1999

BIOCHECK IGE ELISA, MODEL BC-1035

Immunology · 55d