DEHYDROEPIANDROSTERONE SULFATE KIT RIA

Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

RADIOASSAY SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Dehydroepiandrosterone Sulfate Kit Ria.

Pre-market Notification Details

Device IDK802195
510k NumberK802195
Device Name:DEHYDROEPIANDROSTERONE SULFATE KIT RIA
ClassificationRadioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Applicant RADIOASSAY SYSTEMS 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 Received1980-09-10
Decision Date1980-10-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.