SIMPLIFY D-DIMER, MODEL DCGK1— 510(k) K993276

Substantially Equivalent

Agen Biomedical , Ltd.

FDA 510(k) clearance K993276 for SIMPLIFY D-DIMER, MODEL DCGK1, Substantially Equivalent on 1999-12-14. Applicant: Agen Biomedical , Ltd..

Clearance details

Applicant: Agen Biomedical , Ltd.
Product code: Code GHH
Advisory panel: Hematology
Date received: 1999-09-30
Decision date: 1999-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, Queensland, AU

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