Company ยท US
Medical Analysis Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2004. Name variants (Inc, Corp, punctuation) are merged.
107510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 31 |
| DIF | Drug Mixture Control Materials | 13 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 6 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 |
| CEK | Biuret (Colorimetric), Total Protein | 3 |
| CFR | Hexokinase, Glucose | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 3 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 |
| JFJ | Catalytic Methods, Amylase | 2 |
| JGJ | Photometric Method, Magnesium | 2 |
| JIT | Calibrator, Secondary | 2 |
| JMK | Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase | 2 |
| MSJ | Apolipoproteins | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 5, 2004 | K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL Medical Analysis Systems, Inc. | JJX |
| Aug 16, 2004 | K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H Medical Analysis Systems, Inc. | JJX |
| Apr 28, 2004 | K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 Medical Analysis Systems, Inc. | JJY |
| Oct 9, 2003 | K032826 | MAS PAR TDM Medical Analysis Systems, Inc. | DIF |
| Aug 19, 2003 | K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL Medical Analysis Systems, Inc. | JJY |
| Jul 16, 2003 | K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL Medical Analysis Systems, Inc. | JJX |
| Jul 1, 2003 | K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL Medical Analysis Systems, Inc. | JJW |
| Jul 1, 2003 | K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL Medical Analysis Systems, Inc. | DKC |
| May 30, 2003 | K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 Medical Analysis Systems, Inc. | JJY |
| Apr 28, 2003 | K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL Medical Analysis Systems, Inc. | JJY |
| Mar 14, 2003 | K030679 | MAS LIPID LEVEL 1 AND 2 Medical Analysis Systems, Inc. | JJY |
| Dec 19, 2002 | K023669 | MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA Medical Analysis Systems, Inc. | JJY |
| Dec 17, 2002 | K023867 | MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 Medical Analysis Systems, Inc. | JJY |
| Dec 11, 2002 | K023928 | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL Medical Analysis Systems, Inc. | JJW |
| Oct 31, 2002 | K023307 | MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL Medical Analysis Systems, Inc. | JJX |
| Apr 29, 2002 | K021155 | MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL Medical Analysis Systems, Inc. | JJW |
| Dec 21, 2001 | K013995 | MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL Medical Analysis Systems, Inc. | JJY |
| Dec 7, 2001 | K013734 | MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL Medical Analysis Systems, Inc. | JJY |
| Jul 5, 2001 | K011731 | TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 Medical Analysis Systems, Inc. | JJY |
| Jun 18, 2001 | K011548 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 Medical Analysis Systems, Inc. | JJY |
| Feb 28, 2001 | K010111 | CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK Medical Analysis Systems, Inc. | JJY |
| Jul 5, 2000 | K001758 | DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) Medical Analysis Systems, Inc. | JJY |
| Nov 30, 1999 | K993546 | TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 Medical Analysis Systems, Inc. | JJY |
| Nov 22, 1999 | K992829 | CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 Medical Analysis Systems, Inc. | GGN |
| Aug 30, 1999 | K992430 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 Medical Analysis Systems, Inc. | JJT |
| Dec 9, 1998 | K984277 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 Medical Analysis Systems, Inc. | JJT |
| Sep 14, 1998 | K983127 | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 Medical Analysis Systems, Inc. | DIF |
| Jun 29, 1998 | K982024 | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 Medical Analysis Systems, Inc. | DIF |
| Jun 29, 1998 | K981933 | URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 Medical Analysis Systems, Inc. | JJW |
| Mar 4, 1998 | K980514 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 Medical Analysis Systems, Inc. | JJY |
| Sep 29, 1997 | K973451 | MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 Medical Analysis Systems, Inc. | JJW |
| Apr 8, 1997 | K971058 | DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) Medical Analysis Systems, Inc. | DIF |
| Apr 8, 1997 | K970856 | CARDIOISOZYME, CK/LD ISOENZYME CONTROL Medical Analysis Systems, Inc. | JJT |
| Apr 2, 1997 | K970976 | CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 Medical Analysis Systems, Inc. | JJY |
| Apr 23, 1996 | K960824 | IMMUNOLOGY CONTROL Medical Analysis Systems, Inc. | JJY |
| Apr 3, 1996 | K960862 | LIPID CONTROL Medical Analysis Systems, Inc. | JJY |
| Nov 9, 1995 | K954323 | MAS LIQUID URINALYSIS CONTROL Medical Analysis Systems, Inc. | JJY |
| Oct 11, 1995 | K954322 | TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL Medical Analysis Systems, Inc. | DIF |
| Aug 24, 1995 | K952877 | CSF LIQUID CEREBROSPINAL FLUID CONTROL Medical Analysis Systems, Inc. | JJY |
| Apr 20, 1995 | K951057 | MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2 Medical Analysis Systems, Inc. | DCK |
| Mar 21, 1995 | K944525 | LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3 Medical Analysis Systems, Inc. | JJY |
| Aug 18, 1994 | K941328 | TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 Medical Analysis Systems, Inc. | JJY |
| Jul 20, 1994 | K940433 | DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4 Medical Analysis Systems, Inc. | DIF |
| Jul 13, 1994 | K936166 | CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS Medical Analysis Systems, Inc. | DIF |
| Jul 6, 1994 | K934498 | DOA LIQUID DRUGS OF ABUSE CONTROLS Medical Analysis Systems, Inc. | DIF |
| Apr 26, 1994 | K934650 | CEDIA DAU CONTROLS Medical Analysis Systems, Inc. | DIF |
| Jan 27, 1994 | K935062 | MAS LIQUID URINALYSIS CONTROL Medical Analysis Systems, Inc. | JJW |
| Oct 18, 1993 | K934056 | TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 Medical Analysis Systems, Inc. | JJY |
| Jul 28, 1993 | K931366 | TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3 Medical Analysis Systems, Inc. | JJY |
| Feb 3, 1993 | K926320 | REFLAB SYSTEM PACK LIQUID CO2 REAGENT Medical Analysis Systems, Inc. | CHS |
Newest 50 of 107.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||