510(k) K905643— BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
Substantially EquivalentAgen 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.