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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrin Split Products
510(k) Number K945642
Device Name AGEN DIMERTEST GOLD EIA
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
GHH  
Subsequent Product Code
DAP  
Date Received11/16/1994
Decision Date 10/25/1995
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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