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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Lipoprotein, Antigen, Antiserum, Control
510(k) Number K993345
Device Name K-ASSAY APO AI
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 Number866.5580
Classification Product Code
DER  
Date Received10/05/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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