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510(k) K955040

AT-III CONTROL PLASMA KIT by American Bioproducts Co. — Product Code GGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1996
Date Received
November 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K961579 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (July 10, 1996)
  • K954017 — ASSERACHROM FREE PROTEIN S KIT (November 13, 1995)

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  • K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROL (November 3, 2003)
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