Analytical Control Systems, Inc.
Medical device manufacturer in Fishers, IN.
42510(k) clearances
0PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 10
- GFO Activated Partial Thromboplastin 5
- JJX Single (Specified) Analyte Controls… 5
- GGC Control, Plasma, Abnormal 4
- GJS Test, Time, Prothrombin 4
- DIF Drug Mixture Control Materials 3
- GIZ Plasma, Control, Normal 2
- LCP Assay, Glycosylated Hemoglobin 2
- JPA System, Multipurpose For In Vitro… 2
- JIW Calibrator, Surrogate 1
- JIX Calibrator, Multi-Analyte Mixture 1
- JIY Photometric Method, Iron (Non-Heme) 1
- LAS Drug Specific Control Materials 1
- JIS Calibrator, Primary 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K961892 | Specktin-La Test SetGFO · Traditional | 03/07/1997SE |
| K941115 | Acs Cardio-Trol ControlJJY · Traditional | 07/20/1994SE |
| K940272 | Acs Normal Angiotensin Converting Enzyme ControlJJX · Traditional | 04/20/1994SE |
| K940397 | Acs O Dilvent Protein Dilution MatrixJJY · Traditional | 03/11/1994SE |
| K930477 | Acs Angiotensin Converting Enzyme (Ace) CalibratorJIS · Traditional | 06/07/1993SE |
| K926012 | Acs Apct Reagent, ModifiedGFO · Traditional | 04/27/1993SE |
| K925340 | Coagulation Control Containing HemoglobinJPA · Traditional | 03/23/1993SE |
| K925906 | Normal Angiotensin Converting Enzyme ControlJJX · Traditional | 02/18/1993SE |
| K921223 | Acs Freeze-Dried Aptt ReagentGFO · Traditional | 08/18/1992SE |
| K921118 | Acs Apct ReagentGFO · Traditional | 07/28/1992SE |
| K913249 | Acs ULTRA-1 ThromboplastinGJS · Traditional | 12/04/1991SE |
| K913250 | Acs ULTRA-2 ThromboplastinGJS · Traditional | 11/27/1991SE |
| K913677 | Acs Therapeutic Drug Monit Contols, Level I,Ii,IiiLAS · Traditional | 09/25/1991SE |
| K912102 | Acs Liquid ThromboplastinGJS · Traditional | 08/09/1991SE |
| K911178 | Acs Therapeutic Drug Monitoring Control, Level IIIJJX · Traditional | 05/01/1991SE |
| K911177 | Acs Therapeutic Drug Monitoring Control, Level IIJJX · Traditional | 05/01/1991SE |
| K911176 | Acs Therapeutic Drug Monitoring Control, Level IJJX · Traditional | 05/01/1991SE |
| K911171 | Acs Therapeutic Drug Monit Contr, Set II Level IIIJJY · Traditional | 05/01/1991SE |
| K911170 | Therapeutic Drug Monit Control, Set II, Level IIJIY · Traditional | 05/01/1991SE |
| K911169 | Acs Therapeutic Drug Monit Contr, Set II, Level IJJY · Traditional | 05/01/1991SE |
| K911168 | Acs Therapeutic Drug Monit Contr, Set I, Level IIIDIF · Traditional | 05/01/1991SE |
| K911167 | Acs Therapeutic Drug Monit Contr, Set I, Level IIDIF · Traditional | 05/01/1991SE |
| K910930 | Acs Therapeutic Drug Monitoring Control Set I LE.1DIF · Traditional | 05/01/1991SE |
| K904767 | Acs Cholestrerol/Triglyceride Liquid Linear CalibrJIX · Traditional | 12/26/1990SE |
| K904872 | HDL Cholesterol ControlJJY · Traditional | 12/07/1990SE |
| K904829 | Acs Cholesterol/Triglyceride Liquid ControlJJY · Traditional | 12/06/1990SE |
| K902468 | Acs One-Stage Prothrombin Time ReagentGJS · Traditional | 08/10/1990SE |
| K902556 | Acs Activated Partial Thromboplastin Time TestGFO · Traditional | 08/06/1990SE |
| K902458 | Acs 0.02 M Calcium ChlorideJPA · Traditional | 08/01/1990SE |
| K902457 | Abnormal Glycohemoglobin ControlLCP · Traditional | 07/24/1990SE |
| K902455 | Acs Normal Glycohemoglobin Control (A1C HGB)LCP · Traditional | 07/24/1990SE |
| K894425 | Acs Human Plasma Coagulation Control Level IIIGGC · Traditional | 08/03/1989SE |
| K894338 | Acs Animal Plasma Coagulation Control Level IIIGGC · Traditional | 07/25/1989SE |
| K893971 | Acs Animal Plasma Coagulation Control Level IIGGC · Traditional | 07/25/1989SE |
| K893970 | Acs Human Plasma Coagulation Control Level IIGGC · Traditional | 07/25/1989SE |
| K893784 | Acs Human Plasma Coagulation Control Level IGIZ · Traditional | 06/23/1989SE |
| K893783 | Acs Animal Plasma Coagulation Control Level IGIZ · Traditional | 06/23/1989SE |
| K892213 | Acs Colloid Osmotic Pressure CalibratorJIW · Traditional | 06/21/1989SE |
| K800559 | Sertrol Product # Acs ST 101JJY · Traditional | 03/25/1980SE |
| K800558 | Lipid Control Product # Acs LC 101JJY · Traditional | 03/25/1980SE |
| K800370 | Ck/Ld Isoenzyme Control Prod. #Acs CT101JJY · Traditional | 03/12/1980SE |
| K791825 | Ly-Pro-Trol #ACS-LP101JJY · Traditional | 10/01/1979SE |