FDA 510(k) Application Details - K950134

Device Classification Name Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)

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510(K) Number K950134
Device Name Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Applicant E.I. DUPONT DE NEMOURS & CO., INC.
P.O. BOX 80022
BARLEY MILL PLAZA, P22-1170
WILMINGTON, DE US
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Contact CAROLYN K GEORGE
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Regulation Number 862.3250

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Classification Product Code DLN
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Date Received 01/13/1995
Decision Date 03/21/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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