TOTAL PROTEIN (BIURET) REAGENT SET

Biuret (colorimetric), Total Protein

STERLING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sterling Diagnostics, Inc. with the FDA for Total Protein (biuret) Reagent Set.

Pre-market Notification Details

Device IDK860341
510k NumberK860341
Device Name:TOTAL PROTEIN (BIURET) REAGENT SET
ClassificationBiuret (colorimetric), Total Protein
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 CodeCEK  
CFR Regulation Number862.1635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-29
Decision Date1986-02-11

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