OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181— 510(k) K080435

Substantially Equivalent

Olympus Life Science Research Europa GmbH (Europa)

FDA 510(k) clearance K080435 for OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181, Substantially Equivalent on 2008-09-05. Applicant: Olympus Life Science Research Europa GmbH (Europa).

Clearance details

Applicant
Olympus Life Science Research Europa GmbH (Europa)
Product code
Code CIG
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Center Valley, PA, US
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