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FDA 510(k) Application Details - K152612
Device Classification Name
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
More FDA Info for this Device
510(K) Number
K152612
Device Name
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Applicant
GENMARK DIAGNOSTICS, INCORPORATED
5964 LA PLACE COURT
CARLSBAD, CA 92008 US
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Contact
ALAN MADERAZO
Other 510(k) Applications for this Contact
Regulation Number
862.3360
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Classification Product Code
ODW
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More FDA Info for this Product Code
Date Received
09/14/2015
Decision Date
05/26/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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