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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 K991467
Device Name K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
Applicant
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188
Applicant Contact COLIN GETTY
Correspondent
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188
Correspondent Contact COLIN GETTY
Regulation Number866.5775
Classification Product Code
DHR  
Date Received04/27/1999
Decision Date 06/10/1999
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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