BioCheck, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
14
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0214-2022Class IIT4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intendeOctober 14, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K041619BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116December 17, 2004
K040030BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114June 16, 2004
K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117December 19, 2002
K013062BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITJanuary 8, 2002
K003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119July 20, 2001
K002294BIOCHECK TESTOSTERONE EIA, MODEL BC-1115October 2, 2000
K001022BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061September 26, 2000
K992517BIOCHECK FERRITIN ELISA MODEL BC-1025September 24, 1999
K992528BIOCHECK IGE ELISA, MODEL BC-1035September 21, 1999
K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027July 22, 1999
K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003June 22, 1999
K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001June 22, 1999
K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007June 2, 1999
K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005June 2, 1999