AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT

Radioimmunoassay, Thyroid-stimulating Hormone

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tsh Assay, Lan.0001/2001 240 & 144 Kit.

Pre-market Notification Details

Device IDK882907
510k NumberK882907
Device Name:AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
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 CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-12
Decision Date1988-09-22

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