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510(k) K923504

Device
CHOLESTEROL ENZYMATIC ENDPOINT
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K923504
Product code
CHH  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-10
Date received
1992-07-15
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
John Lamont
Address
Ardmore, Diamond Rd. Crumlin, Bt29 4qy Co. Antrim, N. Ireland IR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CHH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251091LipidsTruvian Health2025-12-30
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

Legacy Summary#

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FDA Review#

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