T-UPTAKE MICROASSAY

Radioimmunoassay, Thyroxine-binding Globulin

DIAMEDIX CORP.

The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for T-uptake Microassay.

Pre-market Notification Details

Device IDK885034
510k NumberK885034
Device Name:T-UPTAKE MICROASSAY
ClassificationRadioimmunoassay, Thyroxine-binding Globulin
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactKiefer, Phd
CorrespondentKiefer, Phd
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeCEE  
CFR Regulation Number862.1685 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-05
Decision Date1989-02-02

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