UREA NITROGEN REAGENT SET

Diacetyl-monoxime, Urea Nitrogen

LIVONIA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Livonia Diagnostics, Inc. with the FDA for Urea Nitrogen Reagent Set.

Pre-market Notification Details

Device IDK844156
510k NumberK844156
Device Name:UREA NITROGEN REAGENT SET
ClassificationDiacetyl-monoxime, Urea Nitrogen
Applicant LIVONIA DIAGNOSTICS, INC. 33041 W. EIGHT MILE RD. Livonia,  MI  48152
ContactWalter H Lambert
CorrespondentWalter H Lambert
LIVONIA DIAGNOSTICS, INC. 33041 W. EIGHT MILE RD. Livonia,  MI  48152
Product CodeCDW  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-24
Decision Date1984-11-13

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