AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT

Radioimmunoassay, Total Triiodothyronine

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tt3 Assay, Lan.0003/2003 240/144 Kit.

Pre-market Notification Details

Device IDK881373
510k NumberK881373
Device Name:AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactFrank J Lyman
CorrespondentFrank J Lyman
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-01
Decision Date1988-05-27

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