510(k) DEN150057
- Device
- Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
- Applicant
- Roche Diagnostics
- 510(k) number
- DEN150057
- Product code
- PQO
- Decision
- Unknown (DENG)
- Decision date
- 2016-12-19
- Date received
- 2015-12-09
- Regulation
- 862.1092
- Classification name
- Anti-Müllerian Hormone Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Edie Eads
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3022178699
- 3008198807
- 9610126
- 8023018
- 2432235
- 2020726
- 9680746
- 2032839
- 1219913
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K170524 | Access AMH | Beckman Coulter, Inc. | 2017-11-13 |