DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD

Radioimmunoassay, Thyroid-stimulating Hormone

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 Aca Plus Immunoassay System Tsh Method.

Pre-market Notification Details

Device IDK922701
510k NumberK922701
Device Name:DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington,  DE  19880
ContactChristopher Bentsen
CorrespondentChristopher Bentsen
E.I. DUPONT DE NEMOURS & CO., INC. DU PONT-BMP22/1152 Wilmington,  DE  19880
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-04
Decision Date1992-09-09

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