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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 K902753
Device Name IMX ULTRASENTITIVE HTSH
Applicant
ABBOTT MFG., INC.
ABBOTT PARK,  IL  60064
Applicant Contact CAROLYN BAIRSTOW
Correspondent
ABBOTT MFG., INC.
ABBOTT PARK,  IL  60064
Correspondent Contact CAROLYN BAIRSTOW
Regulation Number862.1690
Classification Product Code
JLW  
Date Received06/22/1990
Decision Date 07/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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