UREA NITROGEN REAGENT SET

Diacetyl-monoxime, Urea Nitrogen

STERLING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK860419
510k NumberK860419
Device Name:UREA NITROGEN REAGENT SET
ClassificationDiacetyl-monoxime, Urea Nitrogen
Applicant STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights,  MI  48077
ContactDavid L Callender
CorrespondentDavid L Callender
STERLING DIAGNOSTICS, INC. 34210 DEQUINDRE RD. Sterling Heights,  MI  48077
Product CodeCDW  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-04
Decision Date1986-02-11

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