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510(k) K020840

VITAL SCIENTIFIC PT WITH CALCIUM by Vital Scientific N.V. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2002
Date Received
March 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
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)
  • K022046 — VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG CO (July 23, 2002)
  • K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (March 13, 1998)

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