K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT

K002948 · Kamiya Biomedical Co. · DAP · May 18, 2001 · Hematology

Device Facts

• Record ID: K002948
• Device Name: K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
• Applicant: Kamiya Biomedical Co.
• Product Code: DAP · Hematology
• Decision Date: May 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7320
• Device Class: Class 2