DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
FDA 510(k) clearance K190298 · decided 2019-10-04
Clearance details
- K-number
- K190298
- Device name
- DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
- Applicant
- Beckman Coulter Biomedical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-02-11
- Decision date
- 2019-10-04
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- CDD
- Device class
- 2
- Regulation number
- 862.1810
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, recall (Z-2144-2023) | Beckman Coulter Biomedical GmbH | 2023-07-14 |
| Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60 recall (Z-2145-2023) | Beckman Coulter Biomedical GmbH | 2023-07-14 |