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510(k) K912102

ACS LIQUID THROMBOPLASTIN by Analytical Control Systems, Inc. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
May 13, 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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  • K921223 — ACS FREEZE-DRIED APTT REAGENT (August 18, 1992)
  • K921118 — ACS APCT REAGENT (July 28, 1992)

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