K-ASSAY D-DIMER CONTROLS— 510(k) K012422

Substantially Equivalent

Kamiya Biomedical Co.

FDA 510(k) clearance K012422 for K-ASSAY D-DIMER CONTROLS, Substantially Equivalent on 2001-08-21. Applicant: Kamiya Biomedical Co..

Clearance details

Applicant: Kamiya Biomedical Co.
Product code: Code GGC
Advisory panel: Hematology
Date received: 2001-07-30
Decision date: 2001-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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