AMERLEX FREE T-3 RIA KIT

Radioimmunoassay, Total Triiodothyronine

AMERSHAM CORP.

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

Pre-market Notification Details

Device IDK830980
510k NumberK830980
Device Name:AMERLEX FREE T-3 RIA KIT
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant AMERSHAM CORP. 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 Received1983-03-29
Decision Date1983-05-25

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