PHASE II T3 RADIOIMMUNOASSAY KIT

Radioimmunoassay, Total Triiodothyronine

MEDICAL & SCIENTIFIC DESIGNS, INC.

The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Phase Ii T3 Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK831064
510k NumberK831064
Device Name:PHASE II T3 RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant MEDICAL & SCIENTIFIC DESIGNS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-04
Decision Date1983-05-09

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