VIDAS THYROXINE (T4) ASSAY (T4)

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

BIOMERIEUX VITEK, INC.

The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Thyroxine (t4) Assay (t4).

Pre-market Notification Details

Device IDK926393
510k NumberK926393
Device Name:VIDAS THYROXINE (T4) ASSAY (T4)
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
ContactVickie Anastasi
CorrespondentVickie Anastasi
BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-21
Decision Date1993-05-13

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