Aperio GT 450 DX; Aperio GT 180 DX— 510(k) K253554
Substantially EquivalentLeica Biosystems Imaging, Inc.
FDA 510(k) clearance K253554 for Aperio GT 450 DX; Aperio GT 180 DX, Substantially Equivalent on 2026-08-07. Applicant: Leica Biosystems Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Leica Biosystems Imaging, Inc.
- Product code
- Code PSY
- Device class
- Class 2
- Regulation
- 21 CFR 864.3700
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vista, CA, US
Recent devices under product code PSY
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