OLYMPUS TOTAL BILIRUBIN REAGENT

Diazo Colorimetry, Bilirubin

OLYMPUS CORP.

The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Total Bilirubin Reagent.

Pre-market Notification Details

Device IDK924964
510k NumberK924964
Device Name:OLYMPUS TOTAL BILIRUBIN REAGENT
ClassificationDiazo Colorimetry, Bilirubin
Applicant OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-30
Decision Date1992-12-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590060176 K924964 000
15099590020040 K924964 000
15099590010119 K924964 000

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