Panels › Clinical Chemistry › Product code PQO · Class 2
Anti-Müllerian Hormone Test System
Regulation 862.1092
0510(k)s in 12 months (5 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in PQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter, Inc. | 2 | 0 |
| Roche Diagnostics | 2 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2023 | K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) Siemens Healthcare Diagnostics, Inc. | PQO |
| Feb 3, 2023 | K223679 | Access AMH Beckman Coulter, Inc. | PQO |
| Jun 10, 2022 | K203757 | Elecsys AMH Roche Diagnostics | PQO |
| Nov 13, 2017 | K170524 | Access AMH Beckman Coulter, Inc. | PQO |
| Dec 19, 2016 | DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 Roche Diagnostics | PQO |
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