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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 K900240
Device Name DELFIA TBG 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 Number862.1685
Classification Product Code
CEE  
Date Received01/17/1990
Decision Date 03/30/1990
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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