ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
FDA 510(k) clearance K061165 · decided 2006-08-03
Clearance details
- K-number
- K061165
- Device name
- ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01
- Applicant
- Sweden Diagnostics (Us), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-26
- Decision date
- 2006-08-03
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- NHX
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Portage, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EliA Sample Diluent, Article number, 83-1023-01 recall (Z-1253-2017) | Phadia US Inc | 2017-02-24 |