FDA 510(k) Applications Submitted by ROBIN J HELLEN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K020226 |
01/22/2002 |
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 |
HELLEN PROFESSIONAL SERVICES |
| K990258 |
01/27/1999 |
QUANTECH TOTAL B-HCG ASSAY |
QUANTECH LTD. |
| 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. |
| K020595 |
02/22/2002 |
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 |
XENOTOPE DIAGNOSTICS, 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. |
| K981536 |
04/29/1998 |
QUANTECH MYOGLOBIN ASSAY |
HELLEN PROFESSIONAL SERVICES |
| K991741 |
05/21/1999 |
BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 |
BIOCHECK, INC. |
| K051958 |
07/19/2005 |
MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 |
MP BIOMEDICALS, LLC. |
| 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. |
| K012943 |
08/31/2001 |
THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE |
QUANTECH LTD. |
| K013062 |
09/12/2001 |
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT |
BIOCHECK, INC. |
| K033566 |
11/12/2003 |
MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 |
RAPID DIAGNOSTICS, INC. |
| K003851 |
12/12/2000 |
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 |
BIOCHECK, INC. |
| K984433 |
12/14/1998 |
QUANTECH CK-MB ASSAY |
QUANTECH LTD. |
| K041619 |
06/15/2004 |
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 |
BIOCHECK, INC. |
| K023505 |
10/18/2002 |
VBL SERUM TROPONIN I TEST, MODEL 1001 |
VANCOUVER BIOTECH LTD. |
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