K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT— 510(k) K002948
Substantially EquivalentKamiya Biomedical Co.
FDA 510(k) clearance K002948 for K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT, Substantially Equivalent on 2001-05-18. Applicant: Kamiya Biomedical Co.. Device class: 2.
Clearance details
- Applicant
- Kamiya Biomedical Co.
- Product code
- Code DAP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code DAP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.