FLOW-PAC CPK REAGENT SET

Colorimetric Method, Cpk Or Isoenzymes

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 Cpk Reagent Set.

Pre-market Notification Details

Device IDK832977
510k NumberK832977
Device Name:FLOW-PAC CPK REAGENT SET
ClassificationColorimetric Method, Cpk Or Isoenzymes
Applicant AMERICAN RESEARCH PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHY  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-02
Decision Date1984-04-05

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