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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K012422
Device Name K-ASSAY D-DIMER CONTROLS
Applicant
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188
Applicant Contact DON TRAN
Correspondent
Kamiya Biomedical Co.
910 Industry Dr.
Seattle,  WA  98188
Correspondent Contact DON TRAN
Regulation Number864.5425
Classification Product Code
GGC  
Date Received07/30/2001
Decision Date 08/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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