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510(k) K973628

VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA by Vital Scientific N.V. — Product Code JJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1998
Date Received
September 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type

Other clearances by Vital Scientific N.V.

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  • K022046 — VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG CO (July 23, 2002)
  • K020840 — VITAL SCIENTIFIC PT WITH CALCIUM (May 15, 2002)

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  • K013654 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (June 5, 2002)
  • K012966 — ROCHE COBAS TAQMAN ANALYZER (February 1, 2002)
  • K993634 — CARESIDE ANALYZER (December 2, 1999)
  • K980056 — CARESIDE ANALYZER (March 6, 1998)
  • K973177 — MAGO AUTOMATED EIA PROCESSOR (October 9, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)
  • K964506 — ROCHE COBAS AMPLICOR ANALYZER (May 21, 1997)