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FDA 510(k) Application Details - K954496
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K954496
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
BOEHRINGER MANNHEIM CORP.
1700 ROCKVILLE PIKE
SUITE 450
ROCKVILLE, MD 20852 US
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Contact
STEVE REITZLER
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Regulation Number
862.3250
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Classification Product Code
DIO
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More FDA Info for this Product Code
Date Received
09/27/1995
Decision Date
03/06/1996
Decision
SESE - SUBST EQUIV
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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