ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT

Radioimmunoassay, Estradiol

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 Estradiol Direct Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK841947
510k NumberK841947
Device Name:ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Estradiol
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCHP  
CFR Regulation Number862.1260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-14
Decision Date1984-06-25

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