K-ASSAY IGM— 510(k) K993323
Substantially EquivalentKamiya Biomedical Co.
FDA 510(k) clearance K993323 for K-ASSAY IGM, Substantially Equivalent on 1999-11-30. Applicant: Kamiya Biomedical Co.. Device class: 2.
Clearance details
- Applicant
- Kamiya Biomedical Co.
- Product code
- Code CFF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.