Company ยท US
Analytical Control Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1997. Name variants (Inc, Corp, punctuation) are merged.
42510(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) | 10 |
| GFO | Activated Partial Thromboplastin | 5 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 |
| GGC | Control, Plasma, Abnormal | 4 |
| GJS | Test, Time, Prothrombin | 4 |
| DIF | Drug Mixture Control Materials | 3 |
| GIZ | Plasma, Control, Normal | 2 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| JIS | Calibrator, Primary | 1 |
| JIW | Calibrator, Surrogate | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 |
| LAS | Drug Specific Control Materials | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 7, 1997 | K961892 | SPECKTIN-LA TEST SET Analytical Control Systems, Inc. | GFO |
| Jul 20, 1994 | K941115 | ACS CARDIO-TROL CONTROL Analytical Control Systems, Inc. | JJY |
| Apr 20, 1994 | K940272 | ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL Analytical Control Systems, Inc. | JJX |
| Mar 11, 1994 | K940397 | ACS O DILVENT PROTEIN DILUTION MATRIX Analytical Control Systems, Inc. | JJY |
| Jun 7, 1993 | K930477 | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR Analytical Control Systems, Inc. | JIS |
| Apr 27, 1993 | K926012 | ACS APCT REAGENT, MODIFIED Analytical Control Systems, Inc. | GFO |
| Mar 23, 1993 | K925340 | COAGULATION CONTROL CONTAINING HEMOGLOBIN Analytical Control Systems, Inc. | JPA |
| Feb 18, 1993 | K925906 | NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL Analytical Control Systems, Inc. | JJX |
| Aug 18, 1992 | K921223 | ACS FREEZE-DRIED APTT REAGENT Analytical Control Systems, Inc. | GFO |
| Jul 28, 1992 | K921118 | ACS APCT REAGENT Analytical Control Systems, Inc. | GFO |
| Dec 4, 1991 | K913249 | ACS ULTRA-1 THROMBOPLASTIN Analytical Control Systems, Inc. | GJS |
| Nov 27, 1991 | K913250 | ACS ULTRA-2 THROMBOPLASTIN Analytical Control Systems, Inc. | GJS |
| Sep 25, 1991 | K913677 | ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III Analytical Control Systems, Inc. | LAS |
| Aug 9, 1991 | K912102 | ACS LIQUID THROMBOPLASTIN Analytical Control Systems, Inc. | GJS |
| May 1, 1991 | K911178 | ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III Analytical Control Systems, Inc. | JJX |
| May 1, 1991 | K911177 | ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II Analytical Control Systems, Inc. | JJX |
| May 1, 1991 | K911176 | ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I Analytical Control Systems, Inc. | JJX |
| May 1, 1991 | K911171 | ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III Analytical Control Systems, Inc. | JJY |
| May 1, 1991 | K911170 | THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II Analytical Control Systems, Inc. | JIY |
| May 1, 1991 | K911169 | ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I Analytical Control Systems, Inc. | JJY |
| May 1, 1991 | K911168 | ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III Analytical Control Systems, Inc. | DIF |
| May 1, 1991 | K911167 | ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II Analytical Control Systems, Inc. | DIF |
| May 1, 1991 | K910930 | ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1 Analytical Control Systems, Inc. | DIF |
| Dec 26, 1990 | K904767 | ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR Analytical Control Systems, Inc. | JIX |
| Dec 7, 1990 | K904872 | HDL CHOLESTEROL CONTROL Analytical Control Systems, Inc. | JJY |
| Dec 6, 1990 | K904829 | ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL Analytical Control Systems, Inc. | JJY |
| Aug 10, 1990 | K902468 | ACS ONE-STAGE PROTHROMBIN TIME REAGENT Analytical Control Systems, Inc. | GJS |
| Aug 6, 1990 | K902556 | ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST Analytical Control Systems, Inc. | GFO |
| Aug 1, 1990 | K902458 | ACS 0.02 M CALCIUM CHLORIDE Analytical Control Systems, Inc. | JPA |
| Jul 24, 1990 | K902457 | ABNORMAL GLYCOHEMOGLOBIN CONTROL Analytical Control Systems, Inc. | LCP |
| Jul 24, 1990 | K902455 | ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) Analytical Control Systems, Inc. | LCP |
| Aug 3, 1989 | K894425 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III Analytical Control Systems, Inc. | GGC |
| Jul 25, 1989 | K894338 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III Analytical Control Systems, Inc. | GGC |
| Jul 25, 1989 | K893971 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II Analytical Control Systems, Inc. | GGC |
| Jul 25, 1989 | K893970 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II Analytical Control Systems, Inc. | GGC |
| Jun 23, 1989 | K893784 | ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I Analytical Control Systems, Inc. | GIZ |
| Jun 23, 1989 | K893783 | ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I Analytical Control Systems, Inc. | GIZ |
| Jun 21, 1989 | K892213 | ACS COLLOID OSMOTIC PRESSURE CALIBRATOR Analytical Control Systems, Inc. | JIW |
| Mar 25, 1980 | K800559 | SERTROL PRODUCT # ACS ST 101 Analytical Control Systems, Inc. | JJY |
| Mar 25, 1980 | K800558 | LIPID CONTROL PRODUCT # ACS LC 101 Analytical Control Systems, Inc. | JJY |
| Mar 12, 1980 | K800370 | CK/LD ISOENZYME CONTROL PROD. #ACS CT101 Analytical Control Systems, Inc. | JJY |
| Oct 1, 1979 | K791825 | LY-PRO-TROL #ACS-LP101 Analytical Control Systems, Inc. | JJY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||