ABBOTT ARCHITECT FREE T4

Radioimmunoassay, Free Thyroxine

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Free T4.

Pre-market Notification Details

Device IDK123379
510k NumberK123379
Device Name:ABBOTT ARCHITECT FREE T4
ClassificationRadioimmunoassay, Free Thyroxine
Applicant ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park,  IL  60064 -3500
ContactJacek Gorzowski
CorrespondentJacek Gorzowski
ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park,  IL  60064 -3500
Product CodeCEC  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1695 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-01
Decision Date2012-11-27
Summary:summary

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