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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 K123965
Device Name COBAS INTEGRA BILIRUBIN DIRECT GEN.2
Applicant
Roche Diagnostics
9115 S. Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Susan Hollandbeck
Correspondent
Roche Diagnostics
9115 S. Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Susan Hollandbeck
Regulation Number862.1110
Classification Product Code
CIG  
Date Received12/26/2012
Decision Date 02/28/2013
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
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