DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
FDA 510(k) clearance K023285 · decided 2002-10-09
Clearance details
- K-number
- K023285
- Device name
- DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-16
- Decision date
- 2002-10-09
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- NHX
- Device class
- 2
- Regulation number
- 866.5775
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Dundee, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Axis-Shield Diagnostics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |