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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 K903215
Device Name LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM
Applicant
Bioproducts For Science, Inc.
P.O. Box 29176
Indianapolis,  IN  46229
Applicant Contact DWIGHT R OWENS
Correspondent
Bioproducts For Science, Inc.
P.O. Box 29176
Indianapolis,  IN  46229
Correspondent Contact DWIGHT R OWENS
Regulation Number866.5630
Classification Product Code
JZG  
Date Received07/23/1990
Decision Date 09/25/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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