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510(k) K780734

ANTICONVULSANTS II CALIBRATOR KIT by Vitek Systems, Inc. — Product Code DIY

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, Ethosuximide
Device Class
Class II
Regulation Number
862.3380
Review Panel
TX
Submission Type

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