510(k) K002948— K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT

Substantially Equivalent

Kamiya Biomedical Co.

Clearance details

Applicant: Kamiya Biomedical Co.
Product code: Code DAP
Advisory panel: Hematology
Date received: 2000-09-21
Decision date: 2001-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

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