FDA 510(k) Application Details - K791979

Device Classification Name Thin Layer Chromatography, Diphenylhydantoin

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510(K) Number K791979
Device Name Thin Layer Chromatography, Diphenylhydantoin
Applicant TECHNICON INSTRUMENTS CORP.


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Regulation Number 862.3350

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Classification Product Code DPE
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Date Received 09/25/1979
Decision Date 11/13/1979
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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