ALDOCTK-125

Radioimmunoassay, Aldosterone

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 Aldoctk-125.

Pre-market Notification Details

Device IDK800775
510k NumberK800775
Device Name:ALDOCTK-125
ClassificationRadioimmunoassay, Aldosterone
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCJM  
CFR Regulation Number862.1045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-07
Decision Date1980-04-21

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