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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, Rheumatoid Factor
510(k) Number K863238
Device Name READS RF TEST KIT FOR IGM RHEUMATOID FACTOR
Applicant
Biostar Medical Products, Inc.
Suite 1203 Crystal Plaza Bld.1
2001 Jefferson Davis, Box 2286
Arlington,  VA  22202
Applicant Contact JERRY BERKSTRESSER
Correspondent
Biostar Medical Products, Inc.
Suite 1203 Crystal Plaza Bld.1
2001 Jefferson Davis, Box 2286
Arlington,  VA  22202
Correspondent Contact JERRY BERKSTRESSER
Regulation Number866.5775
Classification Product Code
DHR  
Date Received08/21/1986
Decision Date 10/08/1986
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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