DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

Radioimmunoassay, Free Thyroxine

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Exl With Lm Clinical Chemistry System, Dimension Ft4l Flex Reagent Cartridge, And Loci Thyroid Calibrator, Mod.

Pre-market Notification Details

Device IDK073604
510k NumberK073604
Device Name:DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
ClassificationRadioimmunoassay, Free Thyroxine
Applicant DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark,  DE  19714 -6101
ContactYuk-ting Lewis
CorrespondentYuk-ting Lewis
DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark,  DE  19714 -6101
Product CodeCEC  
Subsequent Product CodeJIT
Subsequent Product CodeJJE
CFR Regulation Number862.1695 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-21
Decision Date2008-03-13
Summary:summary

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