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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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