510(k) K170524
- Device
- Access AMH
- Applicant
- Beckman Coulter, Inc.
- 510(k) number
- K170524
- Product code
- PQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-13
- Date received
- 2017-02-22
- Regulation
- 862.1092
- Classification name
- Anti-müllerian Hormone Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Debbie Kidder
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 2432235
- 9610126
- 3008198807
- 2032839
- 3022178699
- 1219913
- 2020726
- 8023018
- 9680746
Source Documents#
Other 510(k) Records For Product Code PQO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | Siemens Healthcare Diagnostics, Inc. | 2023-06-02 |
| K223679 | Access AMH | Beckman Coulter, Inc. | 2023-02-03 |
| K203757 | Elecsys AMH | Roche Diagnostics | 2022-06-10 |
| DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | Roche Diagnostics | 2016-12-19 |
Legacy Summary#
summary
FDA Review#
Decision Summary