DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD

Colorimetry, Salicylate

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 Dimension(r) Salicylate(sal) Method.

Pre-market Notification Details

Device IDK904301
510k NumberK904301
Device Name:DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
ClassificationColorimetry, Salicylate
Applicant E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington,  DE  19898
ContactRichard M Vaught
CorrespondentRichard M Vaught
E.I. DUPONT DE NEMOURS & CO., INC. MEDICAL PRODUCTS DEPARTMENT BARLEY MILL PLAZA, P22-1170 Wilmington,  DE  19898
Product CodeDKJ  
CFR Regulation Number862.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-19
Decision Date1990-11-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768005435 K904301 000

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