K-ASSAY AT-III— 510(k) K000361
Substantially EquivalentKamiya Biomedical Co.
FDA 510(k) clearance K000361 for K-ASSAY AT-III, Substantially Equivalent on 2000-04-26. Applicant: Kamiya Biomedical Co.. Device class: 2.
Clearance details
- Applicant
- Kamiya Biomedical Co.
- Product code
- Code JBQ
- Device class
- Class 2
- Regulation
- 21 CFR 864.7060
- Advisory panel
- Hematology
- 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.