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
K872311 ABBOTT LABORATORIES ABBOTT A-GENT LIQUID MAGNESIUM REAGENT 07/09/1987
K944202 ABBOTT LABORATORIES ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED 11/14/1994
K173294 Abbott Laboratories Magnesium 05/18/2018
K981192 ABBOTT LABORATORIES MG 05/01/1998
K981791 ABBOTT LABORATORIES MG 10/23/1998
K850381 ADVANCED BIOMEDICAL METHODS, INC. MAGNESIUM REAGENT FOR DEMAND ANALYZER 03/01/1985
K122302 ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC ACE MAGNESIUM REGENT 08/27/2012
K852005 ALPKEM CORP. MG REAGENT 06/25/1985
K800327 ALTA DIAGNOSTICS, INC. MAGNESIUM REAGENT 03/25/1980
K840784 AMERICAN DADE PARAMAX MAGNESIUM REAGENT 04/13/1984
K802091 AMERICAN MONITOR CORP. AMERICAN MONITOR MAGNESIUM #'S 1036&4021 10/10/1980
K905544 AMRESCO, INC. MAGNESIUM REAGENT 12/27/1990
K821102 ANCO MEDICAL REAGENTS & ASSOC. MEGNESIUM REAGENT KIT 05/05/1982
K873530 BAXTER HEALTHCARE CORP. PARAMAX MAGNESIUM REAGENT 12/14/1987
K883967 BECKMAN INSTRUMENTS, INC. BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD 01/27/1989
K810084 BIO-ANALYTICS LABORATORIES, INC. MAGNESIUM KIT 01/26/1981
K921677 BIOTROL, USA, INC. BIOTROL MAGNESIUM (MAGON) 05/26/1992
K873180 BIOTROL, USA, INC. BIOTROL MAGNESIUM CALMAGITE 09/02/1987
K983416 BOEHRINGER MANNHEIM CORP. ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 10/21/1998
K991717 CARESIDE, INC. CARESIDE MG 08/10/1999
K903341 CATACHEM, INC. MAGNESIUM 08/22/1990
K040508 CLINICAL DATA, INC. VITALAB MAGNESIUM REAGENT 03/08/2004
K851657 COOPER BIOMEDICAL, INC. DEMAND MAGNESIUM 05/10/1985
K901265 COULTER CORP. COULTER MAGNESIUM REAGENT 03/29/1990
K844278 DATA MEDICAL ASSOCIATES, INC. DATA-CHEM MAGNESIUM 01/08/1985
K861668 DATA MEDICAL ASSOCIATES, INC. MAGNESIUM PROCEDURE 05/27/1986
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
K843031 DIAGNOSTIC CHEMICALS, LTD. (USA) MAGNESIUM ASSAY KIT 08/27/1984
K912825 DIAGNOSTIC CHEMICALS, LTD. (USA) MAGNESIUM ASSAY KIT, CAT.# 100-12 07/26/1991
K861386 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG) 08/26/1986
K874576 EASTMAN KODAK COMPANY KODAK EKTACHEM DT SLIDES (MG) 01/21/1988
K030010 ELAN DIAGNOSTICS ATAC PAK MAGNESIUM REAGENT 03/10/2003
K913764 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 11/05/1991
K870553 EM DIAGNOSTIC SYSTEMS, INC. EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX 03/06/1987
K935183 EM DIAGNOSTIC SYSTEMS, INC. EMDS MAGNESIUM (MG) TEST 12/09/1993
K863002 EM DIAGNOSTIC SYSTEMS, INC. EMDS(TM) MAGNESIUM TESTPACKS, #67671/95 08/19/1986
K894508 EM DIAGNOSTIC SYSTEMS, INC. MAGNESIUM TEST ITEM NUMBER: 65419 08/31/1989
K885022 EM DIAGNOSTIC SYSTEMS, INC. MAGNESIUM TEST ITEM NUMBER: SR1019 01/17/1989
K890798 EM DIAGNOSTIC SYSTEMS, INC. REVISED MAGNESIUM TEST ITEM NUMBER: SR1019 03/31/1989
K820976 GILFORD DIAGNOSTICS GIL CHEM MAGNESIUM REAGENT 04/26/1982
K926144 HERAEUS KULZER, INC. URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS 01/27/1993
K930074 HORIZON DIAGNOSTICS, INC. IN-VITRO DIAGNOSTIC REAGENT SET 05/11/1993
K771469 INSTRUMENTATION LABORATORY CO. MULTISTAT III MAGNESIUM TEST 09/12/1977
K863069 J. D. ASSOC. MAGNESIOMETER 12/31/1986
K003835 JAS Diagnostics, Inc. JAS MAGNESIUM REAGENT 03/23/2001
K923927 KING DIAGNOSTICS, INC. KING DIAGNOSTICS MAGNESIUM REAGENT 09/30/1992
K843893 LIVONIA DIAGNOSTICS, INC. MAGNESIUM REAGENT SET 10/30/1984
K803088 MALLINCKRODT CRITICAL CARE MAGNESIUM TEST KIT 01/02/1981
K092737 MEDICA CORP. EASYRA MG REAGENT, MODEL 10220 11/17/2009
K881300 MEDICAL ANALYSIS SYSTEMS, INC. MAGNESIUM LIQUID STABLE REAGENT SET 05/17/1988
K891355 MEDICAL ANALYSIS SYSTEMS, INC. MAGNESIUM REAGENT 03/28/1989
K912321 NOVA BIOMEDICAL CORP. MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK 06/17/1991
K944407 OLYMPUS AMERICA, INC. OLYMPUS MAGNESIUM REAGENT 12/27/1994
K923411 OLYMPUS CORP. OLYMPUS MAGNESIUM REAGENT 08/18/1992
K924658 OLYMPUS CORP. OLYMPUS MAGNESIUM REAGENT 10/19/1992
K853592 POINTE SCIENTIFIC, INC. MAGNESIUM 09/16/1985
K943001 PRISMA SYSTEMS MAGNESIUM QVET 12/29/1994
K162200 RANDOX LABORATORIES LTD Randox RX Daytona Plus Magnesium (MG) 04/28/2017
K974606 RANDOX LABORATORIES, LTD. RANDOX MAGNESIUM 02/12/1998
K874822 REAGENTS APPLICATIONS, INC. RAICHEM(TM) MAGNESIUM REAGENT 01/21/1988
K880880 REAGENTS APPLICATIONS, INC. RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC 05/27/1988
K901758 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE REAGENT FOR MAGNESIUM 05/23/1990
K952426 SCHIAPPARELLI BIOSYSTEMS, INC. MAGNESIUM REAGENT 08/07/1995
K111915 SEKISUI DIAGNOSTICS P.E.I. INC. MAGNESIUM ASSAY 12/02/2011
K162399 SIEMENS HEALTHCARE DIAGNOSTICS, INC. Atellica CH Magnesium (Mg) 01/19/2017
K841259 SIGMA CHEMICAL CO. DETERMINATION OF MAGNESIUM IN SERUM OR 05/07/1984
K883972 SIGMA CHEMICAL CO. MAGNESIUM REAGENT (MAGON SULFONATE) 11/10/1988
K874595 SIMMLER, INC. MULTICHEM (R) MAGNESIUM REAGENT 01/21/1988
K883170 STANBIO LABORATORY STANBIO MAGNESIUM TEST SET, CAT. NO 0130 02/07/1989
K860215 STERLING DIAGNOSTICS, INC. MAGNESIUM REAGENT SET 02/11/1986
K902919 SYNERMED, INC. SYNERMED MAGNESIUM REAGENT KIT 07/31/1990
K874847 TECH-CO, INC. MAGNESIUM 12/18/1987
K882256 TECH-NEAL SCIENTIFIC, INC. MAGNESIUM REAGENT SET 08/08/1988
K901124 TECHNICON INSTRUMENTS CORP. CHEM I CLINICAL ANALYZER "URINE MAGNESIUM" 05/14/1990
K853853 TECHNICON INSTRUMENTS CORP. TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC 10/03/1985
K903306 TECHNICON INSTRUMENTS CORP. TECHNICON CHEM I SYSTEM MAGNESIUM METHOD 08/29/1990
K883326 TECHNICON INSTRUMENTS CORP. TECHNICON RA(TM) SYSTEMS - MAGNESIUM 10/13/1988
K884600 TECHNICON INSTRUMENTS CORP. TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM 01/23/1989
K874506 TECHNICON INSTRUMENTS CORP. USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R) 01/22/1988
K855190 TECHNOSTICS INTL. MAGNESIUM REAGENT SET 02/18/1986
K920603 TRACE AMERICA, INC. TRACE MAGNESIUM - ARSENAZO REAGENT 03/11/1992
K870370 TRACE SCIENTIFIC LTD. MAGNESIUM REAGENT - CALMAGITE METHOD 08/19/1987
K792399 VOLU SOL MEDICAL INDUSTRIES ELVI MAGNESIUM 12/07/1979
K834075 WAKO CHEMICALS, USA, INC. MAGNESIUM B TEST 02/03/1984
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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