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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 K131544
Device Name COBAS C BILIRUBIN TOTAL GEN.3
Applicant
Roche Diagnostics
9115 S. Hague Rd.
Indianapolis,  IN  46250
Applicant Contact LISA K KLINEDINST
Correspondent
Roche Diagnostics
9115 S. Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact LISA K KLINEDINST
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
MQM  
Date Received05/29/2013
Decision Date 07/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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