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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mycophenolic Acid Test System
510(k) Number K063520
Device Name ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact KERWIN KAUFMAN
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact KERWIN KAUFMAN
Regulation Number862.3840
Classification Product Code
OAV  
Subsequent Product Codes
DLJ   LAS  
Date Received11/21/2006
Decision Date 02/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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