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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name drug metabolizing enzyme genotyping systems
De Novo Number DEN040011
510(K) Number K042259
Device Name AMPLICHIP CYP450 TEST, MODEL 04381866190
Requester
roche molecular systems, inc.
4300 hacienda drive
pleasanton,  CA  94588 -2722
Contact james f kelly
Regulation Number862.3360
Classification Product Code
NTI  
Date Received12/20/2004
Decision Date 12/23/2004
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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