FDA 510(k) Application Details - K780734

Device Classification Name Gas Chromatography, Ethosuximide

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510(K) Number K780734
Device Name Gas Chromatography, Ethosuximide
Applicant VITEK SYSTEMS, INC.

, US
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Regulation Number 862.3380

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Classification Product Code DIY
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Date Received 05/02/1978
Decision Date 06/22/1978
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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