Medical Device Manufacturer · US , Northridge , CA

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

14 submissions · 14 cleared · Since 1999

14

Total

14

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared Dec 17, 2004

BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116

Chemistry · 185d

Cleared Dec 19, 2002

BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117

Chemistry · 132d

Cleared Jan 08, 2002

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT

Chemistry · 118d

Cleared Jul 20, 2001

BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT,...

Chemistry · 220d

Cleared Oct 02, 2000

BIOCHECK TESTOSTERONE EIA, MODEL BC-1115

Chemistry · 67d

Cleared Jul 22, 1999

BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027

Chemistry · 62d

Cleared Jun 22, 1999

BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT

Chemistry · 90d

Cleared Jun 22, 1999

TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001

Chemistry · 78d

Cleared Jun 02, 1999

TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005

Chemistry · 47d

Cleared Jun 02, 1999

BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007

Chemistry · 37d