DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE

Radioimmunoassay, Follicle-stimulating Hormone

DUPONT MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Dupont Medical Products with the FDA for Dupont Aca Plus Immunoassay System Follicle Stimulating Hormone.

Pre-market Notification Details

Device IDK941221
510k NumberK941221
Device Name:DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
Applicant DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington,  DE  19880 -0022
ContactRebecca S Ayash
CorrespondentRebecca S Ayash
DUPONT MEDICAL PRODUCTS P.O. BOX 80022, BMP 22-1174 Wilmington,  DE  19880 -0022
Product CodeCGJ  
CFR Regulation Number862.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-14
Decision Date1994-07-20

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