AMERLEX-MAB FT4 KIT

Radioimmunoassay, Free Thyroxine

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-mab Ft4 Kit.

Pre-market Notification Details

Device IDK894091
510k NumberK894091
Device Name:AMERLEX-MAB FT4 KIT
ClassificationRadioimmunoassay, Free Thyroxine
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactFrank J Lyman
CorrespondentFrank J Lyman
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeCEC  
CFR Regulation Number862.1695 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-09
Decision Date1989-08-03

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