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