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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 K920300
Device Name B2-MICROGLOBULIN RADIOIMMUNOASSAY
Applicant
Nichols Institute
33608 Ortega Highway
San Juan Capistrano,  CA  92690
Applicant Contact SALVADORE PALOMARES
Correspondent
Nichols Institute
33608 Ortega Highway
San Juan Capistrano,  CA  92690
Correspondent Contact SALVADORE PALOMARES
Regulation Number866.5630
Classification Product Code
JZG  
Date Received01/22/1992
Decision Date 03/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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