UREA NITROGEN (BUN) LIQUID REAGENT

Urease And Glutamic Dehydrogenase, Urea Nitrogen

JAS DIAGNOSTIC, INC.

The following data is part of a premarket notification filed by Jas Diagnostic, Inc. with the FDA for Urea Nitrogen (bun) Liquid Reagent.

Pre-market Notification Details

Device IDK011596
510k NumberK011596
Device Name:UREA NITROGEN (BUN) LIQUID REAGENT
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
Applicant JAS DIAGNOSTIC, INC. 7220 NW 58TH ST. Miami,  FL  33166
ContactDavid Johnston
CorrespondentDavid Johnston
JAS DIAGNOSTIC, INC. 7220 NW 58TH ST. Miami,  FL  33166
Product CodeCDQ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-24
Decision Date2001-07-17
Summary:summary

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