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510(k) K251058

Tru Kidney Health Test Panel; Tru Analyzer by Truvian Health — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2025
Date Received
April 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Truvian Health

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  • K251091 — Lipids (December 30, 2025)
  • K251074 — Tru Liver Health Test Panel (December 19, 2025)

Other clearances for product code CGX

  • K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer (January 9, 2026)
  • K242685 — Atellica® CH Creatinine_3 (Crea3) (December 4, 2024)
  • K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer (November 19, 2024)
  • K210452 — Creatinine2 (March 22, 2022)
  • K161494 — Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (November 15, 2016)
  • K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (January 27, 2014)
  • K133728 — DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE (January 24, 2014)
  • K123586 — EASYRA CREATININE REAGENT (May 15, 2013)
  • K110530 — ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PE (April 30, 2012)
  • K083809 — CREATININE (April 7, 2009)