FDA 510(k) Applications Submitted by MEDICAL ANALYSIS SYSTEMS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K981933 |
06/02/1998 |
URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K010111 |
01/12/2001 |
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K011548 |
05/18/2001 |
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K011731 |
06/05/2001 |
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K960824 |
02/29/1996 |
IMMUNOLOGY CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K960862 |
03/01/1996 |
LIPID CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K041194 |
05/06/2004 |
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K983127 |
09/08/1998 |
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K042717 |
09/30/2004 |
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K992829 |
08/23/1999 |
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K030679 |
03/04/2003 |
MAS LIPID LEVEL 1 AND 2 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K030942 |
03/26/2003 |
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K040880 |
04/05/2004 |
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K021155 |
04/10/2002 |
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K031364 |
04/30/2003 |
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K031392 |
05/02/2003 |
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K031441 |
05/06/2003 |
URICHEMTRAK LIQUID ASSAYED URINE CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K031890 |
06/18/2003 |
MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K032335 |
07/29/2003 |
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K032826 |
09/10/2003 |
MAS PAR TDM |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K023307 |
10/03/2002 |
MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K023669 |
10/31/2002 |
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K013734 |
11/13/2001 |
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K023867 |
11/20/2002 |
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K023928 |
11/25/2002 |
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K013995 |
12/04/2001 |
MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K970856 |
03/10/1997 |
CARDIOISOZYME, CK/LD ISOENZYME CONTROL |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K970976 |
03/17/1997 |
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K971058 |
03/24/1997 |
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K982024 |
06/09/1998 |
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K993546 |
10/19/1999 |
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K001758 |
06/09/2000 |
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K992430 |
07/21/1999 |
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K973451 |
09/11/1997 |
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K984277 |
11/30/1998 |
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
| K980514 |
02/10/1998 |
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 |
MEDICAL ANALYSIS SYSTEMS, INC. |
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