DIMERTEST(R) LATEX— 510(k) K882944

Substantially Equivalent

Agen Biomedical , Ltd.

FDA 510(k) clearance K882944 for DIMERTEST(R) LATEX, Substantially Equivalent on 1988-08-17. Applicant: Agen Biomedical , Ltd..

Clearance details

Applicant: Agen Biomedical , Ltd.
Product code: Code DAP
Advisory panel: Hematology
Date received: 1988-07-14
Decision date: 1988-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, AU

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