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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 K882944
Device Name DIMERTEST(R) LATEX
Applicant
Agen Biomedical , Ltd.
11 Durbell St., Acacia Ridge
Brisbane,  AU 4110
Applicant Contact RUSSELL RICHARDS
Correspondent
Agen Biomedical , Ltd.
11 Durbell St., Acacia Ridge
Brisbane,  AU 4110
Correspondent Contact RUSSELL RICHARDS
Regulation Number864.7320
Classification Product Code
DAP  
Date Received07/14/1988
Decision Date 08/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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