ADVIA Centaur® Anti-Müllerian Hormone (AMH)— 510(k) K221801
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K221801 for ADVIA Centaur® Anti-Müllerian Hormone (AMH), Substantially Equivalent on 2023-06-02. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code PQO
- Device class
- Class 2
- Regulation
- 21 CFR 862.1092
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code PQO
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