UREA NITROGEN, KINETIC

O-phthalaldehyde, Urea Nitrogen

BIO-ANALYTICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-analytics Laboratories, Inc. with the FDA for Urea Nitrogen, Kinetic.

Pre-market Notification Details

Device IDK810087
510k NumberK810087
Device Name:UREA NITROGEN, KINETIC
ClassificationO-phthalaldehyde, Urea Nitrogen
Applicant BIO-ANALYTICS LABORATORIES, INC. 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 Received1981-01-13
Decision Date1981-02-26

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