FDA 510(k) Application Details - K781941

Device Classification Name Liquid Chromatography, Diphenylhydantoin

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510(K) Number K781941
Device Name Liquid Chromatography, Diphenylhydantoin
Applicant E.I. DUPONT DE NEMOURS & CO., INC.

, US
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Regulation Number 862.3350

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Classification Product Code DOZ
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Date Received 11/20/1978
Decision Date 01/03/1979
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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