FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
xR IVD
K Number: K241868
·
Decision Sep 19, 2025
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
3
Review Days
449
Basic Information
- Device Name
- xR IVD
- K Number
- K241868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6080
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tempus AI, Inc.
- Date Received
- June 27, 2024
- Decision Date
- September 19, 2025
- Product Code
- PZM
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PZM | Next Generation Sequencing Based Tumor Profiling Test | FDA class 2 | Pathology |
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