CODE IM 2050 AMERLEX FREE T4 RIA KIT

Radioimmunoassay, Free Thyroxine

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Code Im 2050 Amerlex Free T4 Ria Kit.

Pre-market Notification Details

Device IDK810231
510k NumberK810231
Device Name:CODE IM 2050 AMERLEX FREE T4 RIA KIT
ClassificationRadioimmunoassay, Free Thyroxine
Applicant AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEC  
CFR Regulation Number862.1695 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-27
Decision Date1981-02-10

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