OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT

Nadh Oxidation/nad Reduction, Alt/sgpt

OLYMPUS CORP.

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

Pre-market Notification Details

Device IDK925339
510k NumberK925339
Device Name:OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT
ClassificationNadh Oxidation/nad Reduction, Alt/sgpt
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 CodeCKA  
CFR Regulation Number862.1030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-20
Decision Date1993-02-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590060022 K925339 000
15099590010065 K925339 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.