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

Substantially Equivalent

Agen Biomedical , Ltd.

FDA 510(k) clearance K905643 for BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY, Substantially Equivalent on 1991-04-12. Applicant: Agen Biomedical , Ltd..

Clearance details

Applicant: Agen Biomedical , Ltd.
Product code: Code GHH
Advisory panel: Hematology
Date received: 1990-12-17
Decision date: 1991-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, AU

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