BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
FDA 510(k) clearance K003291 · decided 2000-12-05
Clearance details
- K-number
- K003291
- Device name
- BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
- Applicant
- Bayer Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-20
- Decision date
- 2000-12-05
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- JZO
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Medfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) recall (Z-3304-2024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-27 |
| Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test) recall (Z-3305-2024) | Siemens Healthcare Diagnostics, Inc. | 2024-09-27 |