510(k) K251058

Device
Tru Kidney Health Test Panel; Tru Analyzer
Applicant
Truvian Health
510(k) number
K251058
Product code
CGX
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-26
Date received
2025-04-04
Regulation
862.1225
Classification name
Alkaline Picrate, Colorimetry, Creatinine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Tho Tran
Address
10300 Campus Pt. Dr. Suite 190 San Diego CA US 92121 92121

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K071280SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMSBeckman Coulter, Inc.2007-06-01
K071283SYNCHRON SYSTEMS CREATININE REAGENTBeckman Coulter, Inc.2007-06-01
K061193CREATININEAbbott Laboratories, Inc.2006-06-23