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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 K991136
Device Name B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Applicant Contact LAURA STORMS TYLER
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Correspondent Contact LAURA STORMS TYLER
Regulation Number866.5630
Classification Product Code
JZG  
Date Received04/05/1999
Decision Date 05/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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