Medical Device Manufacturer · US , Northridge , CA

Biocheck, Inc.

14 submissions · 14 cleared · Since 1999
14
Total
14
Cleared
0
Denied

Biocheck, Inc. — FDA 510(k) Submissions

Biocheck, Inc. has submitted 14 FDA 510(k) premarket notifications since 1999, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Thyroid-stimulating Hormone, Immunoassay Method, Troponin Subunit, Amplifier And Signal Conditioner, Biopotential, System, Test, C-reactive Protein, Radioimmunoassay, Total Triiodothyronine . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
K041619 · MMI Immunoassay Method,... · Chemistry
Dec 2004 185d
BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
K040030 · DCN System, Test, C-reactive... · Immunology
Jun 2004 161d
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
K022660 · DRR Amplifier And Signal... · Chemistry
Dec 2002 132d
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
K013062 · MMI Immunoassay Method,... · Chemistry
Jan 2002 118d
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
K003851 · DCK C-reactive Protein,... · Chemistry
Jul 2001 220d
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
K002294 · CDZ Radioimmunoassay,... · Chemistry
Oct 2000 67d
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
K001022 · JZG System, Test,... · Immunology
Sep 2000 180d
BIOCHECK FERRITIN ELISA MODEL BC-1025
K992517 · DBF Ferritin, Antigen,... · Immunology
Sep 1999 58d
BIOCHECK IGE ELISA, MODEL BC-1035
K992528 · DGC Ige, Antigen, Antiserum,... · Immunology
Sep 1999 55d
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
K991741 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jul 1999 62d
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003
K990993 · JLW Radioimmunoassay,... · Chemistry
Jun 1999 90d
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
K991146 · JLW Radioimmunoassay,... · Chemistry
Jun 1999 78d
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
K991311 · CDP Radioimmunoassay, Total... · Chemistry
Jun 1999 47d
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
K991432 · KLI Enzyme Immunoassay,... · Chemistry
Jun 1999 37d
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