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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 K900440
Device Name AIA-PACK BMG
Applicant
Tosoh Medics, Inc.
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Tosoh Medics, Inc.
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number866.5630
Classification Product Code
JZG  
Date Received01/29/1990
Decision Date 02/26/1990
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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