CORTISOL RADIOIMMUNOASSAY KIT

Radioimmunoassay, Cortisol

TECHNIA DIAGNOSTICS LTD.

The following data is part of a premarket notification filed by Technia Diagnostics Ltd. with the FDA for Cortisol Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK801203
510k NumberK801203
Device Name:CORTISOL RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Cortisol
Applicant TECHNIA DIAGNOSTICS LTD. 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 Received1980-05-19
Decision Date1980-06-09

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