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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Haptoglobin, Antigen, Antiserum, Control
510(k) Number K993480
Device Name K-ASSAY HAPTOGLOBIN
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 Number866.5460
Classification Product Code
DAD  
Date Received10/14/1999
Decision Date 11/24/1999
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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