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510(k) K861973

D-DI TEST KIT by American Bioproducts Co. — Product Code GHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1986
Date Received
May 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrin Split Products
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

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  • K964718 — STA D-DI CALIBRATOR KIT (May 23, 1997)
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  • K962674 — STA - VWF CONTROL [N]+[P] KIT (July 23, 1996)
  • K961579 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (July 10, 1996)
  • K955040 — AT-III CONTROL PLASMA KIT (January 31, 1996)

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  • K972316 — OPUS D-DIMER (September 9, 1997)