ADVIA Centaur® TSH3-Ultra II (TSH3ULII)— 510(k) K233050
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K233050 for ADVIA Centaur® TSH3-Ultra II (TSH3ULII), Substantially Equivalent on 2024-04-04. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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- K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
More clearances from Siemens Healthcare Diagnostics, Inc.
view allAdverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.