AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT

Radioimmunoassay, Thyroxine-binding Globulin

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tbg Assay, Lan.0005/1005 240/144 Test Kit.

Pre-market Notification Details

Device IDK893469
510k NumberK893469
Device Name:AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
ClassificationRadioimmunoassay, Thyroxine-binding Globulin
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 CodeCEE  
CFR Regulation Number862.1685 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-05-04
Decision Date1989-08-15

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