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FDA 510(k) Application Details - K981388
Device Classification Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
More FDA Info for this Device
510(K) Number
K981388
Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant
MICRODIAGNOSTICS, INC.
28062 FORBES ROAD, SUITE B
LAGUNA NIGUEL, CA 92677 US
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Contact
ROY CHUNG
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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
04/16/1998
Decision Date
05/29/1998
Decision
SESE - SUBST EQUIV
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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