FDA 510(k) Application Details - K792429

Device Classification Name Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)

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510(K) Number K792429
Device Name Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Applicant TECKNAM, INC.

, US
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Regulation Number 862.3250

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Classification Product Code DLN
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Date Received 11/28/1979
Decision Date 12/07/1979
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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