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510(k) K930477

ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR by Analytical Control Systems, Inc. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1993
Date Received
January 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K940397 — ACS O DILVENT PROTEIN DILUTION MATRIX (March 11, 1994)
  • K926012 — ACS APCT REAGENT, MODIFIED (April 27, 1993)
  • K925340 — COAGULATION CONTROL CONTAINING HEMOGLOBIN (March 23, 1993)
  • K925906 — NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL (February 18, 1993)
  • K921223 — ACS FREEZE-DRIED APTT REAGENT (August 18, 1992)
  • K921118 — ACS APCT REAGENT (July 28, 1992)
  • K913249 — ACS ULTRA-1 THROMBOPLASTIN (December 4, 1991)

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