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JGJ — Photometric Method, Magnesium Class I

FDA Device Classification

Classification Details

Product Code
JGJ
Device Class
Class I
Regulation Number
862.1495
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K181748abbott laboratoriesMagnesiumSeptember 12, 2018
K173294abbott laboratoriesMagnesiumMay 18, 2018
K162200randox laboratoriesRandox RX Daytona Plus Magnesium (MG)April 28, 2017
K162399siemens healthcare diagnosticsAtellica CH Magnesium (Mg)January 19, 2017
K122302alfa wassermann diagnostics technologiesACE MAGNESIUM REGENTAugust 27, 2012
K111915sekisui diagnostics p.e.iMAGNESIUM ASSAYDecember 2, 2011
K092737medicaEASYRA MG REAGENT, MODEL 10220November 17, 2009
K091910abaxisPICCOLO MAGNESIUM TEST SYSTEMOctober 1, 2009
K063208diagnostic chemicalsMAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7January 19, 2007
K040508clinical dataVITALAB MAGNESIUM REAGENTMarch 8, 2004
K040115abaxisPICCOLO MAGNESIUM TEST SYSTEMJanuary 30, 2004
K030010elan diagnosticsATAC PAK MAGNESIUM REAGENTMarch 10, 2003
K012326wiener laboratories saicWIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001November 8, 2001
K003835jas diagnosticsJAS MAGNESIUM REAGENTMarch 23, 2001
K991761a.p. total careMAGNESIUM PRODUCT NO'S, 112-01, 112-02September 2, 1999
K991717caresideCARESIDE MGAugust 10, 1999
K981791abbott laboratoriesMGOctober 23, 1998
K983416boehringer mannheimROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353October 21, 1998
K981192abbott laboratoriesMGMay 1, 1998
K974606randox laboratoriesRANDOX MAGNESIUMFebruary 12, 1998