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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drug metabolizing enzyme genotyping systems
510(K) Number K042259
Device Name AMPLICHIP CYP450 TEST, MODEL 04381866190
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 hacienda drive
pleasanton,  CA  94588 2722
Contact james f kelly
Regulation Number862.3360
Classification Product Code
NTI  
Date Received09/07/2004
Decision Date 12/23/2004
Decision de novo petitions granted (AN)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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