Medical Analysis Systems, Inc.
Camarillo, CA, US
Medical Analysis Systems, Inc. appears in FDA device records in Camarillo, CA. FDA records list 107 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 107
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 107FDA records hold 107 510(k) clearances for Medical Analysis Systems, Inc. between 1978 and 2004. The busiest year on record is 1978, with 16. The most recent is 2004, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 16 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 7 |
| 1986 | 4 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 7 |
| 1990 | 7 |
| 1991 | 3 |
| 1992 | 3 |
| 1993 | 3 |
| 1994 | 6 |
| 1995 | 5 |
| 1996 | 2 |
| 1997 | 4 |
| 1998 | 5 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 5 |
| 2003 | 8 |
| 2004 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL | JJX | Substantially Equivalent | |
| K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H | JJX | Substantially Equivalent | |
| K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | JJY | Substantially Equivalent | |
| K032826 | MAS PAR TDM | DIF | Substantially Equivalent | |
| K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL | JJY | Substantially Equivalent | |
| K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL | JJX | Substantially Equivalent | |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | JJW | Substantially Equivalent | |
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | DKC | Substantially Equivalent | |
| K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 | JJY | Substantially Equivalent | |
| K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL | JJY | Substantially Equivalent | |
| K030679 | MAS LIPID LEVEL 1 AND 2 | JJY | Substantially Equivalent | |
| K023669 | MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA | JJY | Substantially Equivalent | |
| K023867 | MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3 | JJY | Substantially Equivalent | |
| K023928 | MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL | JJW | Substantially Equivalent | |
| K023307 | MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL | JJX | Substantially Equivalent | |
| K021155 | MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL | JJW | Substantially Equivalent | |
| K013995 | MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL | JJY | Substantially Equivalent | |
| K013734 | MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL | JJY | Substantially Equivalent | |
| K011731 | TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3 | JJY | Substantially Equivalent | |
| K011548 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 | JJY | Substantially Equivalent | |
| K010111 | CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK | JJY | Substantially Equivalent | |
| K001758 | DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) | JJY | Substantially Equivalent | |
| K993546 | TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 | JJY | Substantially Equivalent | |
| K992829 | CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 | GGN | Substantially Equivalent | |
| K992430 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | JJT | Substantially Equivalent | |
| K984277 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | JJT | Substantially Equivalent | |
| K983127 | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3 | DIF | Substantially Equivalent | |
| K982024 | OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3 | DIF | Substantially Equivalent | |
| K981933 | URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2 | JJW | Substantially Equivalent | |
| K980514 | CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 | JJY | Substantially Equivalent | |
| K973451 | MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3 | JJW | Substantially Equivalent | |
| K971058 | DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) | DIF | Substantially Equivalent | |
| K970856 | CARDIOISOZYME, CK/LD ISOENZYME CONTROL | JJT | Substantially Equivalent | |
| K970976 | CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | JJY | Substantially Equivalent | |
| K960824 | IMMUNOLOGY CONTROL | JJY | Substantially Equivalent | |
| K960862 | LIPID CONTROL | JJY | Substantially Equivalent | |
| K954323 | MAS LIQUID URINALYSIS CONTROL | JJY | Substantially Equivalent | |
| K954322 | TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL | DIF | Substantially Equivalent | |
| K952877 | CSF LIQUID CEREBROSPINAL FLUID CONTROL | JJY | Substantially Equivalent | |
| K951057 | MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2 | DCK | Substantially Equivalent | |
| K944525 | LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3 | JJY | Substantially Equivalent | |
| K941328 | TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 | JJY | Substantially Equivalent | |
| K940433 | DOA LIQUID DRUGS OF ABUSE CONTROLS LEVLS 2,3,& 4,G2,G3,& G4 | DIF | Substantially Equivalent | |
| K936166 | CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS | DIF | Substantially Equivalent | |
| K934498 | DOA LIQUID DRUGS OF ABUSE CONTROLS | DIF | Substantially Equivalent | |
| K934650 | CEDIA DAU CONTROLS | DIF | Substantially Equivalent | |
| K935062 | MAS LIQUID URINALYSIS CONTROL | JJW | Substantially Equivalent | |
| K934056 | TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 3 | JJY | Substantially Equivalent | |
| K931366 | TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,3 | JJY | Substantially Equivalent | |
| K926320 | REFLAB SYSTEM PACK LIQUID CO2 REAGENT | CHS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
- KNKAcid, Uric, Uricase (Colorimetric)
- DKCAlcohol Control Materials
- CGXAlkaline Picrate, Colorimetry, Creatinine
- MSJApolipoproteins
- LCPAssay, Glycosylated Hemoglobin
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- CHSCoulometric Method, Carbon-Dioxide
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JJTEnzyme Controls (Assayed And Unassayed)
- CFRHexokinase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- GGNPlasma, Coagulation Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain