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Analytical Control Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
42
Inspections
5
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K961892SPECKTIN-LA TEST SETMarch 7, 1997
K941115ACS CARDIO-TROL CONTROLJuly 20, 1994
K940272ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLApril 20, 1994
K940397ACS O DILVENT PROTEIN DILUTION MATRIXMarch 11, 1994
K930477ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATORJune 7, 1993
K926012ACS APCT REAGENT, MODIFIEDApril 27, 1993
K925340COAGULATION CONTROL CONTAINING HEMOGLOBINMarch 23, 1993
K925906NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROLFebruary 18, 1993
K921223ACS FREEZE-DRIED APTT REAGENTAugust 18, 1992
K921118ACS APCT REAGENTJuly 28, 1992
K913249ACS ULTRA-1 THROMBOPLASTINDecember 4, 1991
K913250ACS ULTRA-2 THROMBOPLASTINNovember 27, 1991
K913677ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,IIISeptember 25, 1991
K912102ACS LIQUID THROMBOPLASTINAugust 9, 1991
K911171ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL IIIMay 1, 1991
K911177ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL IIMay 1, 1991
K911167ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL IIMay 1, 1991
K911169ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL IMay 1, 1991
K911170THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL IIMay 1, 1991
K911178ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL IIIMay 1, 1991