FDA 510(k) Applications Submitted by BIOCHECK, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K990993 |
03/24/1999 |
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 |
BIOCHECK, INC. |
| K992517 |
07/28/1999 |
BIOCHECK FERRITIN ELISA MODEL BC-1025 |
BIOCHECK, INC. |
| K040030 |
01/07/2004 |
BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 |
BIOCHECK, INC. |
| K001022 |
03/30/2000 |
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 |
BIOCHECK, INC. |
| K991146 |
04/05/1999 |
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 |
BIOCHECK, INC. |
| K991311 |
04/16/1999 |
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 |
BIOCHECK, INC. |
| K991432 |
04/26/1999 |
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 |
BIOCHECK, INC. |
| K991741 |
05/21/1999 |
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 |
BIOCHECK, INC. |
| K002294 |
07/27/2000 |
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 |
BIOCHECK, INC. |
| K992528 |
07/28/1999 |
BIOCHECK IGE ELISA, MODEL BC-1035 |
BIOCHECK, INC. |
| K022660 |
08/09/2002 |
BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 |
BIOCHECK, INC. |
| K013062 |
09/12/2001 |
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT |
BIOCHECK, INC. |
| K003851 |
12/12/2000 |
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 |
BIOCHECK, INC. |
| K041619 |
06/15/2004 |
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 |
BIOCHECK, INC. |
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