DIMERTEST LATEX ASSAY— 510(k) K974596

Substantially Equivalent

Agen Biomedical , Ltd.

FDA 510(k) clearance K974596 for DIMERTEST LATEX ASSAY, Substantially Equivalent on 1998-05-26. Applicant: Agen Biomedical , Ltd..

Clearance details

Applicant: Agen Biomedical , Ltd.
Product code: Code DAP
Advisory panel: Hematology
Date received: 1997-12-09
Decision date: 1998-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane 4110, AU

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.