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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 K905643
Device Name BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
Applicant
AGEN BIOMEDICAL LTD.
11 DURBELL ST., ACACIA RIDGE
BRISBANE,  AU 4110
Applicant Contact ROBERT HERRINGTON
Correspondent
AGEN BIOMEDICAL LTD.
11 DURBELL ST., ACACIA RIDGE
BRISBANE,  AU 4110
Correspondent Contact ROBERT HERRINGTON
Regulation Number864.7320
Classification Product Code
GHH  
Date Received12/17/1990
Decision Date 04/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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