510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Analytical Control Systems

Fishers, IN, US

Analytical Control Systems appears in FDA device records in Fishers, IN. FDA records list 42 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
42
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 42 510(k) clearances for Analytical Control Systems between 1979 and 1997. The busiest year on record is 1991, with 13. The most recent is 1997, with 1.

Clearances by year, as a table
510(k) clearance decisions for Analytical Control Systems, by decision year
YearClearances
19791
19803
19897
19908
199113
19922
19934
19943
19971
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K961892SPECKTIN-LA TEST SETGFOSubstantially Equivalent
K941115ACS CARDIO-TROL CONTROLJJYSubstantially Equivalent
K940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLJJXSubstantially Equivalent
K940397ACS O DILVENT PROTEIN DILUTION MATRIXJJYSubstantially Equivalent
K930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORJISSubstantially Equivalent
K926012ACS APCT REAGENT, MODIFIEDGFOSubstantially Equivalent
K925340COAGULATION CONTROL CONTAINING HEMOGLOBINJPASubstantially Equivalent
K925906NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLJJXSubstantially Equivalent
K921223ACS FREEZE-DRIED APTT REAGENTGFOSubstantially Equivalent
K921118ACS APCT REAGENTGFOSubstantially Equivalent
K913249ACS ULTRA-1 THROMBOPLASTINGJSSubstantially Equivalent
K913250ACS ULTRA-2 THROMBOPLASTINGJSSubstantially Equivalent
K913677ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,IIILASSubstantially Equivalent
K912102ACS LIQUID THROMBOPLASTINGJSSubstantially Equivalent
K911178ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL IIIJJXSubstantially Equivalent
K911177ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL IIJJXSubstantially Equivalent
K911176ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL IJJXSubstantially Equivalent
K911171ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL IIIJJYSubstantially Equivalent
K911170THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL IIJIYSubstantially Equivalent
K911169ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL IJJYSubstantially Equivalent
K911168ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL IIIDIFSubstantially Equivalent
K911167ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL IIDIFSubstantially Equivalent
K910930ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1DIFSubstantially Equivalent
K904767ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBRJIXSubstantially Equivalent
K904872HDL CHOLESTEROL CONTROLJJYSubstantially Equivalent
K904829ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROLJJYSubstantially Equivalent
K902468ACS ONE-STAGE PROTHROMBIN TIME REAGENTGJSSubstantially Equivalent
K902556ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TESTGFOSubstantially Equivalent
K902458ACS 0.02 M CALCIUM CHLORIDEJPASubstantially Equivalent
K902457ABNORMAL GLYCOHEMOGLOBIN CONTROLLCPSubstantially Equivalent
K902455ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)LCPSubstantially Equivalent
K894425ACS HUMAN PLASMA COAGULATION CONTROL LEVEL IIIGGCSubstantially Equivalent
K894338ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IIIGGCSubstantially Equivalent
K893971ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IIGGCSubstantially Equivalent
K893970ACS HUMAN PLASMA COAGULATION CONTROL LEVEL IIGGCSubstantially Equivalent
K893784ACS HUMAN PLASMA COAGULATION CONTROL LEVEL IGIZSubstantially Equivalent
K893783ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IGIZSubstantially Equivalent
K892213ACS COLLOID OSMOTIC PRESSURE CALIBRATORJIWSubstantially Equivalent
K800559SERTROL PRODUCT # ACS ST 101JJYSubstantially Equivalent
K800558LIPID CONTROL PRODUCT # ACS LC 101JJYSubstantially Equivalent
K800370CK/LD ISOENZYME CONTROL PROD. #ACS CT101JJYSubstantially Equivalent
K791825LY-PRO-TROL #ACS-LP101JJYSubstantially Equivalent

Registered establishments

FDA registered establishments for Analytical Control Systems, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
18257401825740Analytical Control Systems9058 Technology Drive, Fishers, IN 46038 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

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