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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Beta-2-Microglobulin Immunological
510(k) Number K844469
Device Name PHARMACIA B2-MICRO EIA
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 Number866.5630
Classification Product Code
JZG  
Date Received11/19/1984
Decision Date 02/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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