ACA(R) DIGITOXIN (DGTX) METHOD

Enzyme Immunoassay, Digitoxin

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 Aca(r) Digitoxin (dgtx) Method.

Pre-market Notification Details

Device IDK891094
510k NumberK891094
Device Name:ACA(R) DIGITOXIN (DGTX) METHOD
ClassificationEnzyme Immunoassay, Digitoxin
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 CodeLFM  
CFR Regulation Number862.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-02
Decision Date1989-04-26

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