AMERLITE TT4 ASSAY (240/480/144 TEST KITS)

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tt4 Assay (240/480/144 Test Kits).

Pre-market Notification Details

Device IDK873976
510k NumberK873976
Device Name:AMERLITE TT4 ASSAY (240/480/144 TEST KITS)
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactDonald E Baker
CorrespondentDonald E Baker
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-29
Decision Date1987-11-05

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