ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG— 510(k) K191533
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K191533 for ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG, Substantially Equivalent on 2019-08-28. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code CDZ
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