OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181

Diazo Colorimetry, Bilirubin

OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA)

The following data is part of a premarket notification filed by Olympus Life Science Research Europa Gmbh (europa) with the FDA for Olympus Direct Bilirubin Reagent, Model Osr6x181.

Pre-market Notification Details

Device IDK080435
510k NumberK080435
Device Name:OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
ClassificationDiazo Colorimetry, Bilirubin
Applicant OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) 3500 CORPORATE PKWAY Center Valley,  PA  18034
ContactStephanie G Donnelly
CorrespondentStephanie G Donnelly
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) 3500 CORPORATE PKWAY Center Valley,  PA  18034
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-19
Decision Date2008-09-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590011680 K080435 000

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