125 I-DEHYDROEPIANDROSTERONE SULFATE

Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

WIEN LABORATORIES, INC.

The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for 125 I-dehydroepiandrosterone Sulfate.

Pre-market Notification Details

Device IDK823200
510k NumberK823200
Device Name:125 I-DEHYDROEPIANDROSTERONE SULFATE
ClassificationRadioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Applicant WIEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJKC  
CFR Regulation Number862.1245 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-26
Decision Date1982-11-29

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