FDA Product Code
FDA Product Code PQO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1092
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | Siemens Healthcare Diagnostics, Inc. | 2023-06-02 | Traditional | PDF ↗ |
| K223679 | Access AMH | Beckman Coulter, Inc. | 2023-02-03 | Traditional | PDF ↗ |
| K203757 | Elecsys AMH | Roche Diagnostics | 2022-06-10 | Traditional | PDF ↗ |
| K170524 | Access AMH | Beckman Coulter, Inc. | 2017-11-13 | Traditional | PDF ↗ |
| DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | Roche Diagnostics | 2016-12-19 | Direct | — |
Product code PQO · Class II · Clinical Chemistry. Data: openFDA.