OLYMPUS CREATININE REAGENT

Alkaline Picrate, Colorimetry, Creatinine

OLYMPUS CORP.

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

Pre-market Notification Details

Device IDK924692
510k NumberK924692
Device Name:OLYMPUS CREATININE REAGENT
ClassificationAlkaline Picrate, Colorimetry, Creatinine
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 CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-17
Decision Date1992-10-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590060077 K924692 000
15099590010737 K924692 000

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