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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
Applicant Contact james f kelly
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
4300 HACIENDA DRIVE
pleasanton,  CA  94588 -2722
Correspondent Contact james f kelly
Regulation Number862.3360
Classification Product Code
NTI  
Date Received12/27/2004
Decision Date 01/10/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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