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510(k) K251091

Device
Lipids
Applicant
Truvian Health
510(k) number
K251091
Product code
CHH
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-30
Date received
2025-04-10
Regulation
862.1175
Classification name
Enzymatic Esterase--Oxidase, Cholesterol
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

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

Other 510(k) Records For Product Code CHH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A2024-08-09
K203597Cholesterol2Abbott Ireland Diagnostics Division2022-06-30
K190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.2019-03-27
K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings2018-10-18
K180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.2018-03-28
K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc.2017-07-11
K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemPolymer Technology Systems, Inc.2016-12-22
K150654CholesterolRandox Laboratories, Ltd.2015-09-29
K132031AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROLAxis-Shield Poc AS2014-03-21
K130200PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEMAbaxis, Inc.2013-02-15
K122757ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-10-05
K120202EON CHOLESTEROL REAGENTVital Diagnostics Pty., Ltd.2012-07-27
K113262ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-07-03
K112538ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-03-29
K111753HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDEHitachi Chemical Diagnostics, Inc.2011-12-14