K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
FDA 510(k) clearance K093137 · decided 2010-09-28
Clearance details
- K-number
- K093137
- Device name
- K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
- Applicant
- Kamiya Biomedical Co.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-05
- Decision date
- 2010-09-28
- Days to decision
- 358 days
- Clearance type
- Traditional
- Product code
- NDY
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tukwila, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.