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510(k) K780733

ANTICONVULSANTS III CALIBRATOR KIT by Vitek Systems, Inc. — Product Code DKH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1978
Date Received
May 2, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

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Other clearances for product code DKH

  • K801276 — DUPONT PREP APPLI. FOR PHENOBARBITAL, (June 20, 1980)