K-ASSAY D-DIMER CONTROLS— 510(k) K012422
Substantially EquivalentKamiya Biomedical Co.
FDA 510(k) clearance K012422 for K-ASSAY D-DIMER CONTROLS, Substantially Equivalent on 2001-08-21. Applicant: Kamiya Biomedical Co.. Device class: 2.
Clearance details
- Applicant
- Kamiya Biomedical Co.
- Product code
- Code GGC
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code GGC
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- K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
- K030687 — K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
Data sourced from openFDA. This site is unofficial and independent of the FDA.