BioCheck, Inc.
FDA Regulatory Profile
BioCheck, Inc. appears in FDA public data with 1 recall, 14 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0214-2022, Class II) was initiated on October 14, 2021. Its most recent 510(k) clearance was granted on December 17, 2004.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0214-2022 | Class II | T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intende | October 14, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K041619 | BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 | December 17, 2004 |
| K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | June 16, 2004 |
| K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | December 19, 2002 |
| K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT | January 8, 2002 |
| K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 | July 20, 2001 |
| K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 | October 2, 2000 |
| K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | September 26, 2000 |
| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | September 24, 1999 |
| K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | September 21, 1999 |
| K991741 | BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 | July 22, 1999 |
| K990993 | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 | June 22, 1999 |
| K991146 | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 | June 22, 1999 |
| K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | June 2, 1999 |
| K991311 | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | June 2, 1999 |