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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 K043576
Device Name ROCHE AMPLICHIP CYP450 TEST
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
4300 hacienda drive
pleasanton,  CA  94588 2722
Contact james f kelly
Regulation Number862.3360
Classification Product Code
NTI  
Date Received12/27/2004
Decision Date 01/10/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Toxicology
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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