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510(k) K080435

OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 by Olympus Life Science Research Europa GmbH (Europa) — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2008
Date Received
February 19, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type

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