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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoelectrophoretic, Immunoglobulins, (G, A, M)
510(k) Number K993213
Device Name K-ASSAY IGA
Applicant
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188 -3412
Applicant Contact COLIN GETTY
Correspondent
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188 -3412
Correspondent Contact COLIN GETTY
Regulation Number866.5510
Classification Product Code
CFF  
Date Received09/24/1999
Decision Date 11/23/1999
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
Recalls CDRH Recalls
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