510(k) K251074
K251074 is an FDA 510(k) premarket notification submitted by Truvian Health for the device "Tru Liver Health Test Panel". The FDA issued a decision of Substantially Equivalent on December 19, 2025. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Truvian Health has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2025
- Date Received
- April 8, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type