D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

PHOTEC DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for D-chem Total T4 Test Kit For Thyroxine Quantita..

Pre-market Notification Details

Device IDK896329
510k NumberK896329
Device Name:D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah,  NJ  07430
ContactBarry Mcdonald
CorrespondentBarry Mcdonald
PHOTEC DIAGNOSTICS, INC. 200 CORPORATE DR. Mahwah,  NJ  07430
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-02
Decision Date1989-12-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.