Medical Analysis Systems, Inc.
Medical device manufacturer in Camarillo, CA.
107510(k) clearances
0PMA approvals
0recalls
Device types
- 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… 5
- CIG Diazo Colorimetry, Bilirubin 3
- JJT Enzyme Controls (Assayed And Unassayed) 3
- CFR Hexokinase, Glucose 3
- CEK Biuret (Colorimetric), Total Protein 3
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 2
- JFJ Catalytic Methods, Amylase 2
- JGJ Photometric Method, Magnesium 2
- JIT Calibrator, Secondary 2
- MSJ Apolipoproteins 2
- CHH Enzymatic Esterase--Oxidase, Cholesterol 2
- CDQ Urease And Glutamic Dehydrogenase, Urea… 2
- JMK Acid, Alpha-Ketobutyric And Nadh (U.V.)… 2
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 2
- KNK Acid, Uric, Uricase (Colorimetric) 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- DKC Alcohol Control Materials 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K042717 | Mas, Dade and Liquid Assayed Diabetes ControlJJX · Traditional | 11/05/2004SE |
| K041194 | Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and HJJX · Traditional | 08/16/2004SE |
| K040880 | Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3JJY · Traditional | 04/28/2004SE |
| K032826 | Mas Par TDMDIF · Traditional | 10/09/2003SE |
| K032335 | Mas Cardioimmune Probnp, Mas Cardioimmune TLJJY · Traditional | 08/19/2003SE |
| K031890 | Mas Bilirubin Liquid Assayed Bilirubin ControlJJX · Traditional | 07/16/2003SE |
| K031441 | Urichemtrak Liquid Assayed Urine ControlJJW · Traditional | 07/01/2003SE |
| K031392 | Mas Tox Ammonia Controlliquid Assayed Tox Ammonia ControlDKC · Traditional | 07/01/2003SE |
| K031364 | Mas Cardiolmmune Probnp Liquid Assayed Cardiac Marker Control Level 1, 2 and 3JJY · Traditional | 05/30/2003SE |
| K030942 | Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlJJY · Traditional | 04/28/2003SE |
| K030679 | Mas Lipid Level 1 and 2JJY · Traditional | 03/14/2003SE |
| K023669 | Mas Cardioimmune TL Low Level Liquid Assayed Cardiac Marker Control, Dade Cardiac TL Low…JJY · Traditional | 12/19/2002SE |
| K023867 | Mas T-Marker, Level 1,2 and 3, Dade Special-T Marker, Level 1,2 and 3JJY · Traditional | 12/17/2002SE |
| K023928 | Mas Ua Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis ControlJJW · Traditional | 12/11/2002SE |
| K023307 | Mas Diabetes Control - Lyophilized Assayed Diabetes ControlJJX · Traditional | 10/31/2002SE |
| K021155 | Mas Ua Control, Dade Ua Control- Liquid Assayed Urinalysis ControlJJW · Traditional | 04/29/2002SE |
| K013995 | Modification to Mas Cardiolmmune TL; Dade Cardiac TLJJY · Traditional | 12/21/2001SE |
| K013734 | Mas Lipid Control, Liquid Assayed Lipid Control, Level 1 and 2, Dade Lipid Control…JJY · Special | 12/07/2001SE |
| K011731 | Tri-Point Liquimmune Liquid Assayed Control Levels 1,2, and 3JJY · Traditional | 07/05/2001SE |
| K011548 | Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and TDM Control Levels 1, 2, 3JJY · Traditional | 06/18/2001SE |
| K010111 | Cardioimmune TL Cardiac Marker Control Levels 1, 2, 3, and Multi-PackJJY · Traditional | 02/28/2001SE |
| K001758 | Dade Tru-Liquid Moni-Trol Chemistry Control Levels 1, Mid, 2, and S (Assayed)JJY · Traditional | 07/05/2000SE |
| K993546 | Tri-Point, Liquimmune Liquid Assayed Immunoassay Control, Levels 1, 2, and 3JJY · Traditional | 11/30/1999SE |
| K992829 | Cascade Liquid Coagulation Control Levels 1, 2, and 3GGN · Traditional | 11/22/1999SE |
| K992430 | Cardioimmune Cardiac Marker Control Levels 1,2, and 3JJT · Traditional | 08/30/1999SE |
| K984277 | Cardioimmune Cardiac Marker Control Levels 1,2, and 3JJT · Traditional | 12/09/1998SE |
| K983127 | Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels G2 and G3DIF · Traditional | 09/14/1998SE |
| K982024 | Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3DIF · Traditional | 06/29/1998SE |
| K981933 | Urichemtrak Liquid Assayed Control Levels 1 and 2JJW · Traditional | 06/29/1998SE |
| K980514 | Chemtrak Platinum Comprehensive Liquid Assayed Chemistry and TDM Control Level 1, Model…JJY · Traditional | 03/04/1998SE |
| K973451 | Mas Liquid Urinalysis Control Level 1, Level 2 and Level 3JJW · Traditional | 09/29/1997SE |
| K971058 | Doa-Xse, Liquid Drugs of Abuse Control Levels 2,3, and 4 (Sdoa- 202,303,404)DIF · Traditional | 04/08/1997SE |
| K970856 | Cardioisozyme, Ck/Ld Isoenzyme ControlJJT · Traditional | 04/08/1997SE |
| K970976 | Cardioimmune Cardiac Marker Control, Levels 1,2 and 3JJY · Traditional | 04/02/1997SE |
| K960824 | Immunology ControlJJY · Traditional | 04/23/1996SE |
| K960862 | Lipid ControlJJY · Traditional | 04/03/1996SE |
| K954323 | Mas Liquid Urinalysis ControlJJY · Traditional | 11/09/1995SE |
| K954322 | Tri-Point Liquimmune Liquid Assayed Immunoassay ControlDIF · Traditional | 10/11/1995SE |
| K952877 | CSF Liquid Cerebrospinal Fluid ControlJJY · Traditional | 08/24/1995SE |
| K951057 | Mas Liquid Assayed Alcohol/Ammonia Control Level 1 and 2DCK · Traditional | 04/20/1995SE |
| K944525 | Liquid Assayed Tumor Marker Control Level 1, Level 2, Level 3JJY · Traditional | 03/21/1995SE |
| K941328 | Trak Liquid Cerebrospinal Fluid Control Levels 1 & 2JJY · Traditional | 08/18/1994SE |
| K940433 | Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4DIF · Traditional | 07/20/1994SE |
| K936166 | Chemtrak Liquid Unassayed Therapeutic Drug ControlsDIF · Traditional | 07/13/1994SE |
| K934498 | Doa Liquid Drugs of Abuse ControlsDIF · Traditional | 07/06/1994SE |
| K934650 | Cedia Dau ControlsDIF · Traditional | 04/26/1994SE |
| K935062 | Mas Liquid Urinalysis ControlJJW · Traditional | 01/27/1994SE |
| K934056 | Tri-Point Brand Liquimmune Immunoassay Contr 1,2 & 3JJY · Traditional | 10/18/1993SE |
| K931366 | Tri-Point Liquimmune Immuonassay Control, L-1,2,3JJY · Traditional | 07/28/1993SE |
| K926320 | Reflab System Pack Liquid CO2 ReagentCHS · Traditional | 02/03/1993SE |
| K920291 | Moni-Trol-L and Moni-Trol-XlJJY · Traditional | 09/02/1992SE |
| K920397 | Reflab System Pack Liquid Fructosamine ReagentLCP · Traditional | 08/04/1992SE |
| K914204 | Tri-Point Liquimmune Ligand Control Levels 1,2,3JJY · Traditional | 03/17/1992SE |
| K914069 | Reflab(Tm) Brand Syst PK Liq Reagent, Apolipop A-1MSJ · Traditional | 10/02/1991SE |
| K912749 | Reflab(Tm) BR Syst Pack Liq Reag, Apolipoprotein BMSJ · Traditional | 09/23/1991SE |
| K910333 | Challenge (TM) Liq Thera Drug ControlsDIF · Traditional | 04/12/1991SE |
| K904905 | Doa Liquid Multi-Analyte Drugs of Abuse ControlsDIF · Traditional | 12/11/1990SE |
| K904141 | TDM Plus XL Enhanced Liq Drug Control I,Ii,IiiJJY · Traditional | 11/01/1990SE |
| K903310 | Challenge(Tm) Brand Liq Multi-Analyte Linear ContrJJY · Traditional | 09/07/1990SE |
| K903225 | Challenge Brand Liquid Multi-Enzyme Linearity ContJJY · Traditional | 08/17/1990SE |
| K903190 | Moni-Trol XL and L Unassayed Liquid ChemistryJJY · Traditional | 08/17/1990SE |
| K900902 | Iron Liquid Stable ReagentJIY · Traditional | 03/19/1990SE |
| K900259 | Direct Bilirubin ReagentCIG · Traditional | 02/27/1990SE |
| K893730 | Direct Bilirubin ReagentCIG · Traditional | 08/11/1989SE |
| K892393 | Acid Phosphatase ReagentCKB · Traditional | 07/20/1989SE |
| K891155 | Iron ReagentCFM · Traditional | 04/18/1989SE |
| K891355 | Magnesium ReagentJGJ · Traditional | 03/28/1989SE |
| K885078 | Lipase SR Liquid Stable Reagent SetCET · Traditional | 03/13/1989SE |
| K890317 | Total Protein ReagentCEK · Traditional | 03/08/1989SE |
| K885176 | Amylase SR Liquid Stable Reagent SetJFJ · Traditional | 02/17/1989SE |
| K883543 | Hdl-Cholesterol Precipitating ReagentCHH · Traditional | 12/16/1988SE |
| K880152 | Par(Tm) Brand Drug of Abuse ControlsDIF · Traditional | 05/31/1988SE |
| K881300 | Magnesium Liquid Stable Reagent SetJGJ · Traditional | 05/17/1988SE |
| K881200 | Chloride Liquid Stable Reagent SetCHJ · Traditional | 04/28/1988SE |
| K870586 | Tdcontrol Liquid Multi-Analyte Therapeutic DrugDIF · Traditional | 04/01/1987SE |
| K862733 | Amylase SR Liquid Stable Reagent SetJFJ · Traditional | 09/29/1986SE |
| K863095 | Ace II (Tri-Level)JIX · Traditional | 09/26/1986SE |
| K861413 | Bilirubin*Sr (Total) Liquid Stable Reagent SetCIG · Traditional | 04/24/1986SE |
| K855041 | Calcium Liquid Stable Reagent SetCIC · Traditional | 01/22/1986SE |
| K853868 | Albumin SR Liquid Stable Reagent SetCIX · Traditional | 09/30/1985SE |
| K853464 | Glucose SR Liquid Stable Reagent SetCFR · Traditional | 09/04/1985SE |
| K852461 | Chemtrak Liquid Multi-Analyte Calibrator, Mul-SetJIT · Traditional | 07/12/1985SE |
| K852103 | Inorganic Phosphorus Liquid Stable Reagent InorganCEO · Traditional | 05/31/1985SE |
| K851877 | Total Protein Liquid Stable Reagent SetCEK · Traditional | 05/20/1985SE |
| K851849 | Creatine Liquid Stable Reagent SetCGX · Traditional | 05/20/1985SE |
| K851670 | Chem Trak Tri-Point Liquid Bilirubin Calibrator,I/JIT · Traditional | 05/10/1985SE |
| K834518 | Liquid Stable Triglycerides Reagent SetCDT · Traditional | 03/02/1984SE |
| K833097 | Chem Trak Liquid Bilirubin ControlJJX · Traditional | 01/11/1984SE |
| K832941 | Bun Liquid Stable Reagent SetCDQ · Traditional | 10/28/1983SE |
| K821382 | Chemistry Control/StandardJJY · Traditional | 05/28/1982SE |
| K813511 | Uric-AcidKNK · Traditional | 12/31/1981SE |
| K781726 | Reagent Set, SGPT Serum GlutamicCKA · Traditional | 11/03/1978SE |
| K781725 | Reagent Set, U.V. Enzmatic Kinetic, SgotCIT · Traditional | 11/03/1978SE |
| K781724 | Nad Reduction Method, Lactate PyrivateCFJ · Traditional | 11/03/1978SE |
| K781723 | Glucose Hexokinase, Auto KCFR · Traditional | 11/03/1978SE |
| K781722 | Reagent Set, Total ProteinCEK · Traditional | 11/03/1978SE |
| K781721 | Reagent Set, CholesterolCHH · Traditional | 11/03/1978SE |
| K781720 | HBDH Enzyme Kinetic Reagent SetJMK · Traditional | 11/03/1978SE |
| K781719 | CPK Reagent Set, Nad ReductionCGS · Traditional | 11/03/1978SE |
| K781718 | Alp Reagent Set, Alkaline PhosphataseCJE · Traditional | 11/03/1978SE |
| K780072 | Glucose Reagent SetCFR · Traditional | 02/14/1978SE |
| K780071 | Gama-Gpt Reagent SetJQB · Traditional | 02/14/1978SE |
| K780069 | Bun Reagnet SetCDQ · Traditional | 02/14/1978SE |
| K780074 | Ldh-L Reagent Set · Traditional | 02/13/1978SE |
| K780073 | HBDH Reagent SetJMK · Traditional | 02/13/1978SE |
| K780070 | CPK Reagent SetCGS · Traditional | 02/13/1978SE |
| K780068 | Alp Reagent SetCJE · Traditional | 02/07/1978SE |