K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL— 510(k) K093137
Substantially EquivalentKamiya Biomedical Co.
FDA 510(k) clearance K093137 for K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL, Substantially Equivalent on 2010-09-28. Applicant: Kamiya Biomedical Co.. Device class: 2.
Clearance details
- Applicant
- Kamiya Biomedical Co.
- Product code
- Code NDY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tukwila, WA, US
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