IMMUNOSCAN CCPLUS
FDA 510(k) clearance K091657 · decided 2009-11-19
Clearance details
- K-number
- K091657
- Device name
- IMMUNOSCAN CCPLUS
- Applicant
- Euro-Diagnostica AB
- Decision
- Substantially Equivalent
- Date received
- 2009-06-09
- Decision date
- 2009-11-19
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- NHX
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Malmo, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative recall (Z-2918-2018) | Euro Diagnostica AB | 2018-08-23 |