510(k) K221801
- Device
- ADVIA Centaur® Anti-Müllerian Hormone (AMH)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- 510(k) number
- K221801
- Product code
- PQO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-02
- Date received
- 2022-06-21
- 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
- Mey Vasquez
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 2432235
- 9610126
- 3008198807
- 2032839
- 3022178699
- 1219913
- 2020726
- 8023018
- 9680746