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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, total thyroxine
510(k) Number K883559
Device Name DELFIA THYROXINE (T4) KIT
Applicant
PHARMACIA, INC.
800 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3911
Applicant Contact ALBERT P MAYO
Correspondent
PHARMACIA, INC.
800 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3911
Correspondent Contact ALBERT P MAYO
Regulation Number862.1700
Classification Product Code
CDX  
Date Received08/19/1988
Decision Date 12/14/1988
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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