TOTAL ESTROGENS KIT BY RIA

Radioimmunoassay, Total Estrogens, Nonpregnancy

RADIOASSAY SYSTEMS LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK791651
510k NumberK791651
Device Name:TOTAL ESTROGENS KIT BY RIA
ClassificationRadioimmunoassay, Total Estrogens, Nonpregnancy
Applicant RADIOASSAY SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJMD  
CFR Regulation Number862.1275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-21
Decision Date1979-09-27

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