AMERLEX-M FREE T-3 RIA

Radioimmunoassay, Total Triiodothyronine

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Free T-3 Ria.

Pre-market Notification Details

Device IDK842949
510k NumberK842949
Device Name:AMERLEX-M FREE T-3 RIA
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant AMERSHAM CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-06
Decision Date1984-09-05

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