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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K063543
Device Name COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50410
Indianapolis,  IN  46250
Applicant Contact CORINA HARPER
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50410
Indianapolis,  IN  46250
Correspondent Contact CORINA HARPER
Regulation Number862.1110
Classification Product Code
CIG  
Date Received11/24/2006
Decision Date 12/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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