510(k) K203757
- Device
- Elecsys AMH
- Applicant
- Roche Diagnostics
- 510(k) number
- K203757
- Product code
- PQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-10
- Date received
- 2020-12-23
- 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
- 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#
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 |
| K170524 | Access AMH | Beckman Coulter, Inc. | 2017-11-13 |
| DEN150057 | Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 | Roche Diagnostics | 2016-12-19 |
Legacy Summary#
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FDA Review#
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