AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123

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 Amresco Urea Nitrogen (bun) Reagents, Prod # 7123.

Pre-market Notification Details

Device IDK891912
510k NumberK891912
Device Name:AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
ContactC. K Owens
CorrespondentC. K Owens
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 Received1989-03-27
Decision Date1989-06-19

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