ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
FDA 510(k) clearance K052407 · decided 2006-07-18
Clearance details
- K-number
- K052407
- Device name
- ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
- Applicant
- Fisher Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2005-09-01
- Decision date
- 2006-07-18
- Days to decision
- 320 days
- Clearance type
- Traditional
- Product code
- JZO
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Middletown, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT. recall (Z-1843-2025) | Mckesson Medical-Surgical Inc. Corporate Office | 2025-05-27 |
| Alinity i Anti-TPO Reagent Kit, List Number 09P3521 recall (Z-1696-2023) | Abbott Ireland Limited | 2023-06-08 |