FDA 510(k) Application Details - K800364

Device Classification Name Thin Layer Chromatography, Barbiturate

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510(K) Number K800364
Device Name Thin Layer Chromatography, Barbiturate
Applicant HOFFREL INSTRUMENTS, INC.

, US
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Regulation Number 862.3150

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Classification Product Code DKX
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Date Received 02/20/1980
Decision Date 03/12/1980
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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