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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
510(k) Number K974596
Device Name DIMERTEST LATEX ASSAY
Applicant
Agen Biomedical , Ltd.
11durbell St., Acacia
Ridge
Brisbane 4110,  AU
Applicant Contact RUSSELL RICHARDS
Correspondent
Agen Biomedical , Ltd.
11durbell St., Acacia
Ridge
Brisbane 4110,  AU
Correspondent Contact RUSSELL RICHARDS
Regulation Number864.7320
Classification Product Code
DAP  
Date Received12/09/1997
Decision Date 05/26/1998
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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