REAGENT SET, CHOLESTEROL

Enzymatic Esterase--oxidase, Cholesterol

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Reagent Set, Cholesterol.

Pre-market Notification Details

Device IDK781721
510k NumberK781721
Device Name:REAGENT SET, CHOLESTEROL
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant MEDICAL ANALYSIS SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-10-11
Decision Date1978-11-03

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