K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR— 510(k) K091486
Substantially EquivalentKamiya Biomedical Co.
FDA 510(k) clearance K091486 for K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR, Substantially Equivalent on 2010-04-29. Applicant: Kamiya Biomedical Co.. Device class: 2.
Clearance details
- Applicant
- Kamiya Biomedical Co.
- Product code
- Code DCF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5040
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tukwila, WA, US
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