URINARY/CEREBROSPINAL FLUID PROTEIN

Biuret (colorimetric), Total Protein

E.I. DUPONT DE NEMOURS & CO., INC.

The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Urinary/cerebrospinal Fluid Protein.

Pre-market Notification Details

Device IDK934841
510k NumberK934841
Device Name:URINARY/CEREBROSPINAL FLUID PROTEIN
ClassificationBiuret (colorimetric), Total Protein
Applicant E.I. DUPONT DE NEMOURS & CO., INC. BMP22/1170 Wilmington,  DE  19880 -0022
ContactCarlolyn K George
CorrespondentCarlolyn K George
E.I. DUPONT DE NEMOURS & CO., INC. BMP22/1170 Wilmington,  DE  19880 -0022
Product CodeCEK  
CFR Regulation Number862.1635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-08
Decision Date1994-04-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768005459 K934841 000

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