DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR

Calibrator, Multi-analyte Mixture

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 Du Pont Total Protein/albumin Calibrator.

Pre-market Notification Details

Device IDK914917
510k NumberK914917
Device Name:DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR
ClassificationCalibrator, Multi-analyte Mixture
Applicant E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington,  DE  19898
ContactCarolyn K George
CorrespondentCarolyn K George
E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington,  DE  19898
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-04
Decision Date1991-12-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768005091 K914917 000

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