T3 UPTAKE RADIOIMMUNOASSAY KIT

Radioassay, Triiodothyronine Uptake

CAMBRIDGE MEDICAL TECHNOLOGY

The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for T3 Uptake Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK855169
510k NumberK855169
Device Name:T3 UPTAKE RADIOIMMUNOASSAY KIT
ClassificationRadioassay, Triiodothyronine Uptake
Applicant CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
ContactSandra L Fan
CorrespondentSandra L Fan
CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
Product CodeKHQ  
CFR Regulation Number862.1715 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-26
Decision Date1986-02-06

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