510(k) K905643— BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY

Substantially Equivalent

Agen Biomedical , Ltd.

Clearance details

Applicant
Agen Biomedical , Ltd.
Product code
Code GHH
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brisbane, AU
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