AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT

Radioimmunoassay, Free Thyroxine

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Free T-4 Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK842482
510k NumberK842482
Device Name:AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Free Thyroxine
Applicant AMERSHAM CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCEC  
CFR Regulation Number862.1695 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-25
Decision Date1984-08-10

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