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FDA 510(k) Application Details - K073071
Device Classification Name
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
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510(K) Number
K073071
Device Name
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Applicant
TRIMGEN CORPORATION
34 LOVETON CIRCLE, SUITE 210
SPARKS, MD 21152-9202 US
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HOWARD DOONG
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Regulation Number
862.3360
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Classification Product Code
ODW
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Date Received
10/31/2007
Decision Date
02/06/2009
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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