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510(k) K921118

ACS APCT REAGENT by Analytical Control Systems, Inc. — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1992
Date Received
March 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

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  • K926012 — ACS APCT REAGENT, MODIFIED (April 27, 1993)
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  • K921223 — ACS FREEZE-DRIED APTT REAGENT (August 18, 1992)
  • K913249 — ACS ULTRA-1 THROMBOPLASTIN (December 4, 1991)

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