CREATININE REAGENT SET

Alkaline Picrate, Colorimetry, Creatinine

OMEGA MEDICAL ELECTRONICS

The following data is part of a premarket notification filed by Omega Medical Electronics with the FDA for Creatinine Reagent Set.

Pre-market Notification Details

Device IDK821199
510k NumberK821199
Device Name:CREATININE REAGENT SET
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant OMEGA MEDICAL ELECTRONICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-27
Decision Date1982-07-13

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