BUN REAGENT

Urease And Glutamic Dehydrogenase, Urea Nitrogen

AMERICAN RESEARCH PRODUCTS CO.

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

Pre-market Notification Details

Device IDK942984
510k NumberK942984
Device Name:BUN REAGENT
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
ContactLeonard C Szymowski
CorrespondentLeonard C Szymowski
AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
Product CodeCDQ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-20
Decision Date1995-03-01

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