ULTRA-VIOLET BUN REAGENT KIT (RATE)

Urease And Glutamic Dehydrogenase, Urea Nitrogen

BIOCHEMICAL TRADE, INC.

The following data is part of a premarket notification filed by Biochemical Trade, Inc. with the FDA for Ultra-violet Bun Reagent Kit (rate).

Pre-market Notification Details

Device IDK871547
510k NumberK871547
Device Name:ULTRA-VIOLET BUN REAGENT KIT (RATE)
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami,  FL  33152
ContactRoy, Ph.d.
CorrespondentRoy, Ph.d.
BIOCHEMICAL TRADE, INC. P.O. BOX 520575 Miami,  FL  33152
Product CodeCDQ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-20
Decision Date1987-06-22

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