ADVIA Centaur® Anti-Müllerian Hormone (AMH)
FDA 510(k) clearance K221801 · decided 2023-06-02
Clearance details
- K-number
- K221801
- Device name
- ADVIA Centaur® Anti-Müllerian Hormone (AMH)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-21
- Decision date
- 2023-06-02
- Days to decision
- 346 days
- Clearance type
- Traditional
- Product code
- PQO
- Device class
- 2
- Regulation number
- 862.1092
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Access AMH (K223679) | Beckman Coulter, Inc. | 2023-02-03 |
| Elecsys AMH (K203757) | Roche Diagnostics | 2022-06-10 |
| Access AMH (K170524) | Beckman Coulter, Inc. | 2017-11-13 |
| Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 (DEN150057) | Roche Diagnostics | 2016-12-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| IMMULITE 2000 AFP (P010007/S024) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM Anti-HBe2 (aHBe2) (P200017/S005) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM HBc Total 2 (HBcT2) (P210019/S004) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036) | Siemens Healthcare Diagnostics, Inc. | 2025-08-14 |
| ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025) | Siemens Healthcare Diagnostics, Inc. | 2025-07-16 |