INSULIN RADIOIMMUNOASSAY KIT

Radioimmunoassay, Immunoreactive Insulin

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 Insulin Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK841573
510k NumberK841573
Device Name:INSULIN RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Immunoreactive Insulin
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFP  
CFR Regulation Number862.1405 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-17
Decision Date1984-05-16

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