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510(k) K964716

STA LIATEST CONTROL [N]+[P] KIT by American Bioproducts Co. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1997
Date Received
November 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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  • K955040 — AT-III CONTROL PLASMA KIT (January 31, 1996)
  • K954017 — ASSERACHROM FREE PROTEIN S KIT (November 13, 1995)

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