Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Analysis Systems, Inc. — Predicate Candidate Screening
107 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
133 days90th percentile
107clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL | Medical Analysis Systems, Inc. | 2004-11-05 | 36 | 0 |
| K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARK | Medical Analysis Systems, Inc. | 2004-08-16 | 102 | 0 |
| K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, L | Medical Analysis Systems, Inc. | 2004-04-28 | 23 | 0 |
| K032826 | MAS PAR TDM | Medical Analysis Systems, Inc. | 2003-10-09 | 29 | 0 |
| K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL | Medical Analysis Systems, Inc. | 2003-08-19 | 21 | 0 |
| K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL | Medical Analysis Systems, Inc. | 2003-07-16 | 28 | 1 |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | Medical Analysis Systems, Inc. | 2003-07-01 | 56 | 0 |
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | Medical Analysis Systems, Inc. | 2003-07-01 | 60 | 0 |
| K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTRO | Medical Analysis Systems, Inc. | 2003-05-30 | 30 | 0 |
| K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY C | Medical Analysis Systems, Inc. | 2003-04-28 | 33 | 0 |
| K030679 | MAS LIPID LEVEL 1 AND 2 | Medical Analysis Systems, Inc. | 2003-03-14 | 10 | 0 |
| K023669 | MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER | Medical Analysis Systems, Inc. | 2002-12-19 | 49 | 0 |
| K023867 | MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL | Medical Analysis Systems, Inc. | 2002-12-17 | 27 | 0 |
| K023928 | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAY | Medical Analysis Systems, Inc. | 2002-12-11 | 16 | 0 |
| K023307 | MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL | Medical Analysis Systems, Inc. | 2002-10-31 | 28 | 0 |
| K021155 | MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS C | Medical Analysis Systems, Inc. | 2002-04-29 | 19 | 0 |
| K013995 | MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL | Medical Analysis Systems, Inc. | 2001-12-21 | 17 | 0 |
| K013734 | MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND | Medical Analysis Systems, Inc. | 2001-12-07 | 24 | 0 |
| K011731 | TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND | Medical Analysis Systems, Inc. | 2001-07-05 | 30 | 0 |
| K011548 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND | Medical Analysis Systems, Inc. | 2001-06-18 | 31 | 0 |
| K010111 | CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND M | Medical Analysis Systems, Inc. | 2001-02-28 | 47 | 0 |
| K001758 | DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2 | Medical Analysis Systems, Inc. | 2000-07-05 | 26 | 0 |
| K993546 | TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LE | Medical Analysis Systems, Inc. | 1999-11-30 | 42 | 0 |
| K992829 | CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 | Medical Analysis Systems, Inc. | 1999-11-22 | 91 | 0 |
| K992430 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | 1999-08-30 | 40 | 0 |
| K984277 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | 1998-12-09 | 9 | 0 |
| K983127 | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 | Medical Analysis Systems, Inc. | 1998-09-14 | 6 | 0 |
| K982024 | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 | Medical Analysis Systems, Inc. | 1998-06-29 | 20 | 0 |
| K981933 | URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 | Medical Analysis Systems, Inc. | 1998-06-29 | 27 | 0 |
| K980514 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND | Medical Analysis Systems, Inc. | 1998-03-04 | 22 | 0 |
| K973451 | MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 | Medical Analysis Systems, Inc. | 1997-09-29 | 18 | 1 |
| K970856 | CARDIOISOZYME, CK/LD ISOENZYME CONTROL | Medical Analysis Systems, Inc. | 1997-04-08 | 29 | 0 |
| K971058 | DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SD | Medical Analysis Systems, Inc. | 1997-04-08 | 15 | 0 |
| K970976 | CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | Medical Analysis Systems, Inc. | 1997-04-02 | 16 | 0 |
| K960824 | IMMUNOLOGY CONTROL | Medical Analysis Systems, Inc. | 1996-04-23 | 54 | 0 |
| K960862 | LIPID CONTROL | Medical Analysis Systems, Inc. | 1996-04-03 | 33 | 0 |
| K954323 | MAS LIQUID URINALYSIS CONTROL | Medical Analysis Systems, Inc. | 1995-11-09 | 55 | 0 |
| K954322 | TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL | Medical Analysis Systems, Inc. | 1995-10-11 | 26 | 0 |
| K952877 | CSF LIQUID CEREBROSPINAL FLUID CONTROL | Medical Analysis Systems, Inc. | 1995-08-24 | 62 | 0 |
| K951057 | MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2 | Medical Analysis Systems, Inc. | 1995-04-20 | 44 | 0 |
| K944525 | LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL | Medical Analysis Systems, Inc. | 1995-03-21 | 186 | 0 |
| K941328 | TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 | Medical Analysis Systems, Inc. | 1994-08-18 | 153 | 0 |
| K940433 | DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4 | Medical Analysis Systems, Inc. | 1994-07-20 | 170 | 0 |
| K936166 | CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS | Medical Analysis Systems, Inc. | 1994-07-13 | 203 | 0 |
| K934498 | DOA LIQUID DRUGS OF ABUSE CONTROLS | Medical Analysis Systems, Inc. | 1994-07-06 | 294 | 0 |
| K934650 | CEDIA DAU CONTROLS | Medical Analysis Systems, Inc. | 1994-04-26 | 209 | 0 |
| K935062 | MAS LIQUID URINALYSIS CONTROL | Medical Analysis Systems, Inc. | 1994-01-27 | 99 | 0 |
| K934056 | TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 | Medical Analysis Systems, Inc. | 1993-10-18 | 60 | 0 |
| K931366 | TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3 | Medical Analysis Systems, Inc. | 1993-07-28 | 133 | 0 |
| K926320 | REFLAB SYSTEM PACK LIQUID CO2 REAGENT | Medical Analysis Systems, Inc. | 1993-02-03 | 50 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda