SPAC T3 RIA TEST KIT

Radioimmunoassay, Total Triiodothyronine

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Spac T3 Ria Test Kit.

Pre-market Notification Details

Device IDK801125
510k NumberK801125
Device Name:SPAC T3 RIA TEST KIT
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant MALLINCKRODT CRITICAL CARE 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 Received1980-05-12
Decision Date1980-06-09

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