ANDROSTENEDIONE BY RIA

Radioimmunoassay, Androstenedione

RADIOASSAY SYSTEMS LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK842960
510k NumberK842960
Device Name:ANDROSTENEDIONE BY RIA
ClassificationRadioimmunoassay, Androstenedione
Applicant RADIOASSAY SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIZ  
CFR Regulation Number862.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-27
Decision Date1984-09-27

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