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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Fibrinogen
510(k) Number K993482
Device Name K-ASSAY FIBRINOGEN
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 Number864.7340
Classification Product Code
GIS  
Date Received10/14/1999
Decision Date 12/06/1999
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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