CORALENT COAT 125I CORTISOL RADIOIMM.

Radioimmunoassay, Cortisol

RADIOASSAY SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Coralent Coat 125i Cortisol Radioimm..

Pre-market Notification Details

Device IDK791835
510k NumberK791835
Device Name:CORALENT COAT 125I CORTISOL RADIOIMM.
ClassificationRadioimmunoassay, Cortisol
Applicant RADIOASSAY SYSTEMS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGR  
CFR Regulation Number862.1205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-09-17
Decision Date1979-09-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817830022306 K791835 000

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