UREA ASSAY KIT

Urease And Glutamic Dehydrogenase, Urea Nitrogen

DIAGNOSTIC CHEMICALS, LTD. (USA)

The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Urea Assay Kit.

Pre-market Notification Details

Device IDK842242
510k NumberK842242
Device Name:UREA ASSAY KIT
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, 
Product CodeCDQ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-05
Decision Date1984-07-18

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