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510(k) K162200

Device
Randox RX Daytona Plus Magnesium (MG)
Applicant
RANDOX LABORATORIES LTD
510(k) number
K162200
Product code
JGJ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-04-28
Date received
2016-08-05
Regulation
862.1495
Classification name
Photometric Method, Magnesium
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAULINE 0 ARMSTRONG
Address
55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JGJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181748MagnesiumAbbott Laboratories2018-09-12
K173294MagnesiumAbbott Laboratories2018-05-18
K162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc.2017-01-19
K122302ACE MAGNESIUM REGENTAlfa Wassermann Diagnostics Technologies, LLC2012-08-27
K111915MAGNESIUM ASSAYSekisui Diagnostics P.E.I., Inc.2011-12-02
K092737EASYRA MG REAGENT, MODEL 10220Medica Corp.2009-11-17
K091910PICCOLO MAGNESIUM TEST SYSTEMAbaxis, Inc.2009-10-01
K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7Diagnostic Chemicals , Ltd.2007-01-19
K040508VITALAB MAGNESIUM REAGENTClinical Data, Inc.2004-03-08
K040115PICCOLO MAGNESIUM TEST SYSTEMAbaxis, Inc.2004-01-30
K030010ATAC PAK MAGNESIUM REAGENTElan Diagnostics2003-03-10
K012326WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001Wiener Laboratories Saic2001-11-08
K003835JAS MAGNESIUM REAGENTJas Diagnostics, Inc.2001-03-23
K991761MAGNESIUM PRODUCT NO'S, 112-01, 112-02A.P. Total Care, Inc.1999-09-02
K991717CARESIDE MGCareside, Inc.1999-08-10

Legacy Summary#

summary

FDA Review#

Decision Summary