CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK

Radioimmunoassay, Cortisol

SORIN BIOMEDICA, FIAT, USA, INC.

The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Cortisol Radioimmunoassay Kit-cortctk.

Pre-market Notification Details

Device IDK830563
510k NumberK830563
Device Name:CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK
ClassificationRadioimmunoassay, Cortisol
Applicant SORIN BIOMEDICA, FIAT, USA, 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 Received1983-02-23
Decision Date1983-05-13

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