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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, thyroxine-binding globulin
510(k) Number K893469
Device Name AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
Applicant
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Applicant Contact FRANK J LYMAN
Correspondent
AMERSHAM CORP.
2636 SOUTH CLEARBROOK DR.
ARLINGTON HEIGHTS,  IL  60005
Correspondent Contact FRANK J LYMAN
Regulation Number862.1685
Classification Product Code
CEE  
Date Received05/04/1989
Decision Date 08/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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