FDA 510(k) Applications for Medical Device Product Code "JGJ"
(Photometric Method, Magnesium)

FDA 510(k) Number Applicant Device Name Decision Date
K991761 A.P. TOTAL CARE, INC. MAGNESIUM PRODUCT NO'S, 112-01, 112-02 09/02/1999
K040115 ABAXIS, INC. PICCOLO MAGNESIUM TEST SYSTEM 01/30/2004
K091910 ABAXIS, INC. PICCOLO MAGNESIUM TEST SYSTEM 10/01/2009
K173294 Abbott Laboratories Magnesium 05/18/2018
K181748 Abbott Laboratories Magnesium 09/12/2018
K981192 ABBOTT LABORATORIES MG 05/01/1998
K981791 ABBOTT LABORATORIES MG 10/23/1998
K122302 ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC ACE MAGNESIUM REGENT 08/27/2012
K983416 BOEHRINGER MANNHEIM CORP. ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 10/21/1998
K991717 CARESIDE, INC. CARESIDE MG 08/10/1999
K040508 CLINICAL DATA, INC. VITALAB MAGNESIUM REAGENT 03/08/2004
K964915 DERMA MEDIA LAB., INC. MAGNESIUM 03/26/1997
K063208 DIAGNOSTIC CHEMICALS LTD. MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 01/19/2007
K030010 ELAN DIAGNOSTICS ATAC PAK MAGNESIUM REAGENT 03/10/2003
K003835 JAS Diagnostics, Inc. JAS MAGNESIUM REAGENT 03/23/2001
K092737 MEDICA CORP. EASYRA MG REAGENT, MODEL 10220 11/17/2009
K162200 RANDOX LABORATORIES LTD Randox RX Daytona Plus Magnesium (MG) 04/28/2017
K974606 RANDOX LABORATORIES, LTD. RANDOX MAGNESIUM 02/12/1998
K111915 SEKISUI DIAGNOSTICS P.E.I. INC. MAGNESIUM ASSAY 12/02/2011
K162399 SIEMENS HEALTHCARE DIAGNOSTICS, INC. Atellica CH Magnesium (Mg) 01/19/2017
K012326 WIENER LABORATORIES S.A.I.C. WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 11/08/2001


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