FDA 510(k) Application Details - K924113

Device Classification Name Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)

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510(K) Number K924113
Device Name Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC.
1080 U.S. HIGHWAY 202
BRANCHBURG, NJ US
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Contact CAROL L KRIEGER
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Regulation Number 862.3250

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Classification Product Code DLN
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Date Received 08/13/1992
Decision Date 12/28/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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