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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Immunoreactive Insulin
510(k) Number K851071
Device Name PHARMACIA INSULIN RIA
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 Number862.1405
Classification Product Code
CFP  
Date Received03/18/1985
Decision Date 04/12/1985
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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