Atellica IM Total PSA II (tPSAII)— 510(k) K251630
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K251630 for Atellica IM Total PSA II (tPSAII), Substantially Equivalent on 2026-01-05. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code LTJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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More clearances from Siemens Healthcare Diagnostics, Inc.
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