FLOW-PAC SHOLESTEROL REAGENT SET

Enzymatic Esterase--oxidase, Cholesterol

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Flow-pac Sholesterol Reagent Set.

Pre-market Notification Details

Device IDK832780
510k NumberK832780
Device Name:FLOW-PAC SHOLESTEROL REAGENT SET
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant AMERICAN RESEARCH PRODUCTS CO. 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 Received1983-08-16
Decision Date1983-10-14

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