BLOOD UREA NITROGEN REAGENT

O-phthalaldehyde, Urea Nitrogen

CONNECTICUT DIAGNOSTICS, LTD.

The following data is part of a premarket notification filed by Connecticut Diagnostics, Ltd. with the FDA for Blood Urea Nitrogen Reagent.

Pre-market Notification Details

Device IDK792362
510k NumberK792362
Device Name:BLOOD UREA NITROGEN REAGENT
ClassificationO-phthalaldehyde, Urea Nitrogen
Applicant CONNECTICUT DIAGNOSTICS, LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJGZ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-21
Decision Date1979-12-06

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