ISO-SEP SYSTEM

Radioimmunoassay, Total Triiodothyronine

BERWICK MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Berwick Medical Products, Inc. with the FDA for Iso-sep System.

Pre-market Notification Details

Device IDK831434
510k NumberK831434
Device Name:ISO-SEP SYSTEM
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant BERWICK MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-04
Decision Date1983-06-30

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