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FDA 510(k) Application Details - K032057
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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510(K) Number
K032057
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
BRANAN MEDICAL CORP.
10015 MUIRLANDS RD., SUITE E
IRVINE, CA 92618 US
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Contact
RAPHAEL WONG
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Regulation Number
862.3250
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Classification Product Code
DIO
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Date Received
07/02/2003
Decision Date
08/21/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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