AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT

Radioimmunoassay, Total Triiodothyronine

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Ft3 Assay, Lan.0007/2007 240/144 Test Kit.

Pre-market Notification Details

Device IDK885195
510k NumberK885195
Device Name:AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST 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 Received1988-12-16
Decision Date1989-02-08

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