ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
FDA 510(k) clearance K083868 · decided 2009-09-25
Clearance details
- K-number
- K083868
- Device name
- ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-29
- Decision date
- 2009-09-25
- Days to decision
- 270 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT. recall (Z-1853-2025) | Mckesson Medical-Surgical Inc. Corporate Office | 2025-05-27 |