DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
FDA 510(k) clearance K021516 · decided 2002-07-23
Clearance details
- K-number
- K021516
- Device name
- DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-10
- Decision date
- 2002-07-23
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- NHX
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Dundee, Scotland, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200) recall (Z-0003-2007) | Axis-Shield Diagnostics, Ltd. | 2006-10-03 |