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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K904666
Device Name AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
Applicant
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Applicant Contact B PATTERSON
Correspondent
Amersham Corp.
2636 S. Clearbrook Dr.
Arlington Heights,  IL  60005
Correspondent Contact B PATTERSON
Regulation Number862.1690
Classification Product Code
JLW  
Date Received10/15/1990
Decision Date 11/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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