AMRESCO E4A REAGENT SET

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Amresco E4a Reagent Set.

Pre-market Notification Details

Device IDK840868
510k NumberK840868
Device Name:AMRESCO E4A REAGENT SET
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant AMERICAN RESEARCH PRODUCTS CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-27
Decision Date1984-05-22

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