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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Analytical Control Systems, Inc. — Predicate Candidate Screening

42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

50 daysmedian FDA review time
141 days90th percentile
42clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K961892SPECKTIN-LA TEST SETAnalytical Control Systems, Inc.1997-03-072950
K941115ACS CARDIO-TROL CONTROLAnalytical Control Systems, Inc.1994-07-201350
K940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLAnalytical Control Systems, Inc.1994-04-20980
K940397ACS O DILVENT PROTEIN DILUTION MATRIXAnalytical Control Systems, Inc.1994-03-11430
K930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORAnalytical Control Systems, Inc.1993-06-071290
K926012ACS APCT REAGENT, MODIFIEDAnalytical Control Systems, Inc.1993-04-271580
K925340COAGULATION CONTROL CONTAINING HEMOGLOBINAnalytical Control Systems, Inc.1993-03-231540
K925906NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLAnalytical Control Systems, Inc.1993-02-18900
K921223ACS FREEZE-DRIED APTT REAGENTAnalytical Control Systems, Inc.1992-08-181580
K921118ACS APCT REAGENTAnalytical Control Systems, Inc.1992-07-281410
K913249ACS ULTRA-1 THROMBOPLASTINAnalytical Control Systems, Inc.1991-12-041350
K913250ACS ULTRA-2 THROMBOPLASTINAnalytical Control Systems, Inc.1991-11-271280
K913677ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,IIIAnalytical Control Systems, Inc.1991-09-25370
K912102ACS LIQUID THROMBOPLASTINAnalytical Control Systems, Inc.1991-08-09880
K911168ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL IIIAnalytical Control Systems, Inc.1991-05-01470
K911178ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL IIIAnalytical Control Systems, Inc.1991-05-01440
K911169ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL IAnalytical Control Systems, Inc.1991-05-01470
K911167ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL IIAnalytical Control Systems, Inc.1991-05-01470
K911171ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL IIIAnalytical Control Systems, Inc.1991-05-01470
K911177ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL IIAnalytical Control Systems, Inc.1991-05-01440
K911176ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL IAnalytical Control Systems, Inc.1991-05-01440
K911170THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL IIAnalytical Control Systems, Inc.1991-05-01470
K910930ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1Analytical Control Systems, Inc.1991-05-01560
K904767ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBRAnalytical Control Systems, Inc.1990-12-26650
K904872HDL CHOLESTEROL CONTROLAnalytical Control Systems, Inc.1990-12-07380
K904829ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROLAnalytical Control Systems, Inc.1990-12-06420
K902468ACS ONE-STAGE PROTHROMBIN TIME REAGENTAnalytical Control Systems, Inc.1990-08-10670
K902556ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTAnalytical Control Systems, Inc.1990-08-06590
K902458ACS 0.02 M CALCIUM CHLORIDEAnalytical Control Systems, Inc.1990-08-01580
K902455ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)Analytical Control Systems, Inc.1990-07-24500
K902457ABNORMAL GLYCOHEMOGLOBIN CONTROLAnalytical Control Systems, Inc.1990-07-24500
K894425ACS HUMAN PLASMA COAGULATION CONTROL LEVEL IIIAnalytical Control Systems, Inc.1989-08-03170
K894338ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IIIAnalytical Control Systems, Inc.1989-07-25110
K893970ACS HUMAN PLASMA COAGULATION CONTROL LEVEL IIAnalytical Control Systems, Inc.1989-07-25530
K893971ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IIAnalytical Control Systems, Inc.1989-07-25530
K893784ACS HUMAN PLASMA COAGULATION CONTROL LEVEL IAnalytical Control Systems, Inc.1989-06-23320
K893783ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IAnalytical Control Systems, Inc.1989-06-23320
K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORAnalytical Control Systems, Inc.1989-06-21790
K800559SERTROL PRODUCT # ACS ST 101Analytical Control Systems, Inc.1980-03-25130
K800558LIPID CONTROL PRODUCT # ACS LC 101Analytical Control Systems, Inc.1980-03-25130
K800370CK/LD ISOENZYME CONTROL PROD. #ACS CT101Analytical Control Systems, Inc.1980-03-12210
K791825LY-PRO-TROL #ACS-LP101Analytical Control Systems, Inc.1979-10-01140

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