K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C— 510(k) K030687

Substantially Equivalent

Kamiya Biomedical Co.

FDA 510(k) clearance K030687 for K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C, Substantially Equivalent on 2003-06-27. Applicant: Kamiya Biomedical Co..

Clearance details

Applicant: Kamiya Biomedical Co.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2003-03-05
Decision date: 2003-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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