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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 K080435
Device Name OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
Applicant
Olympus Life Science Research Europa GmbH (Europa)
3500 Corporate Pkway
Center Valley,  PA  18034
Applicant Contact STEPHANIE G DONNELLY
Correspondent
Olympus Life Science Research Europa GmbH (Europa)
3500 Corporate Pkway
Center Valley,  PA  18034
Correspondent Contact STEPHANIE G DONNELLY
Regulation Number862.1110
Classification Product Code
CIG  
Date Received02/19/2008
Decision Date 09/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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