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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 K923421
Device Name COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
Applicant
Coulter Corp.
600 Coulter Way
Hialeah,  FL  33010
Applicant Contact MARION S GAIDE
Correspondent
Coulter Corp.
600 Coulter Way
Hialeah,  FL  33010
Correspondent Contact MARION S GAIDE
Regulation Number866.5630
Classification Product Code
JZG  
Date Received07/13/1992
Decision Date 09/23/1992
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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