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510(k) K022046

VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL by Vital Scientific N.V. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2002
Date Received
June 24, 2002
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

Other clearances by Vital Scientific N.V.

  • K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (November 1, 2002)
  • K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (October 25, 2002)
  • K020840 — VITAL SCIENTIFIC PT WITH CALCIUM (May 15, 2002)
  • K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (March 13, 1998)

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