K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
FDA 510(k) clearance K992312 · decided 1999-09-13
Clearance details
- K-number
- K992312
- Device name
- K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATOR B
- Applicant
- Kamiya Biomedical Co.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-09
- Decision date
- 1999-09-13
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- DCK
- Device class
- 2
- Regulation number
- 866.5270
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| K-ASSAY CRP(2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit con recall (Z-0850-06) | Kamiya Biomedical Company | 2006-05-06 |