ALKALINE PHOSPHOTASE REAGENT SET

Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes

OMEGA MEDICAL ELECTRONICS

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

Pre-market Notification Details

Device IDK821200
510k NumberK821200
Device Name:ALKALINE PHOSPHOTASE REAGENT SET
ClassificationThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
Applicant OMEGA MEDICAL ELECTRONICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIO  
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-27
Decision Date1982-07-13

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