AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008

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-60 Assay Product Code: Lan. 0008/2008.

Pre-market Notification Details

Device IDK904666
510k NumberK904666
Device Name:AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactB Patterson
CorrespondentB Patterson
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 Received1990-10-15
Decision Date1990-11-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.