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510(k) K913250

ACS ULTRA-2 THROMBOPLASTIN by Analytical Control Systems, Inc. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1991
Date Received
July 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

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  • K926012 — ACS APCT REAGENT, MODIFIED (April 27, 1993)
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  • 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)

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