Product Code: JGJ FDA class 1 21 CFR 862.1495

Photometric Method, Magnesium

Clinical Chemistry

Photometric Method for Magnesium is a clinical chemistry test system that uses colorimetric or photometric techniques to quantify magnesium levels in serum or plasma, used in the assessment of magnesium metabolism and electrolyte disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JGJ, regulated under 21 CFR 862.1495, within the Clinical Chemistry medical specialty. This device is eligible for third-party review where applicable.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code JGJ in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: JGJ
Device Class: FDA class 1
Regulation Number: 862.1495
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 90 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K181748	Magnesium	Sep 12, 2018	Substantially Equivalent	Abbott Laboratories
K173294	Magnesium	May 18, 2018	Substantially Equivalent	Abbott Laboratories
K162200	Randox RX Daytona Plus Magnesium (MG)	Apr 28, 2017	Substantially Equivalent	Randox Laboratories, Ltd.
K162399	Atellica CH Magnesium (Mg)	Jan 19, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K122302	ACE MAGNESIUM REGENT	Aug 27, 2012	Substantially Equivalent	Alfa Wassermann Diagnostics Technologies, LLC
K111915	MAGNESIUM ASSAY	Dec 02, 2011	Substantially Equivalent	Sekisui Diagnostics P.E.I., Inc.
K092737	EASYRA MG REAGENT, MODEL 10220	Nov 17, 2009	Substantially Equivalent	Medica Corp.
K091910	PICCOLO MAGNESIUM TEST SYSTEM	Oct 01, 2009	Substantially Equivalent	Abaxis, Inc.
K063208	MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7	Jan 19, 2007	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K040508	VITALAB MAGNESIUM REAGENT	Mar 08, 2004	Substantially Equivalent	Clinical Data, Inc.
K040115	PICCOLO MAGNESIUM TEST SYSTEM	Jan 30, 2004	Substantially Equivalent	Abaxis, Inc.
K030010	ATAC PAK MAGNESIUM REAGENT	Mar 10, 2003	Substantially Equivalent	Elan Diagnostics
K012326	WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001	Nov 08, 2001	Substantially Equivalent	Wiener Laboratories Saic
K003835	JAS MAGNESIUM REAGENT	Mar 23, 2001	Substantially Equivalent	Jas Diagnostics, Inc.
K991761	MAGNESIUM PRODUCT NO'S, 112-01, 112-02	Sep 02, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K991717	CARESIDE MG	Aug 10, 1999	Substantially Equivalent	Careside, Inc.
K981791	MG	Oct 23, 1998	Substantially Equivalent	Abbott Laboratories
K983416	ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353	Oct 21, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K981192	MG	May 01, 1998	Substantially Equivalent	Abbott Laboratories
K974606	RANDOX MAGNESIUM	Feb 12, 1998	Substantially Equivalent	Randox Laboratories, Ltd.
K964915	MAGNESIUM	Mar 26, 1997	Substantially Equivalent	Derma Media Lab., Inc.
K952426	MAGNESIUM REAGENT	Aug 07, 1995	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K943001	MAGNESIUM QVET	Dec 29, 1994	Substantially Equivalent	Prisma Systems
K944407	OLYMPUS MAGNESIUM REAGENT	Dec 27, 1994	Substantially Equivalent	Olympus America, Inc.
K944202	ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED	Nov 14, 1994	Substantially Equivalent	Abbott Laboratories
K935183	EMDS MAGNESIUM (MG) TEST	Dec 09, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K930074	IN-VITRO DIAGNOSTIC REAGENT SET	May 11, 1993	Substantially Equivalent	Horizon Diagnostics, Inc.
K926144	URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS	Jan 27, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K924658	OLYMPUS MAGNESIUM REAGENT	Oct 19, 1992	Substantially Equivalent	Olympus Corp.
K923927	KING DIAGNOSTICS MAGNESIUM REAGENT	Sep 30, 1992	Substantially Equivalent	King Diagnostics, Inc.
K923411	OLYMPUS MAGNESIUM REAGENT	Aug 18, 1992	Substantially Equivalent	Olympus Corp.
K921677	BIOTROL MAGNESIUM (MAGON)	May 26, 1992	Substantially Equivalent	Biotrol, USA, Inc.
K920603	TRACE MAGNESIUM - ARSENAZO REAGENT	Mar 11, 1992	Substantially Equivalent	Trace America, Inc.
K913764	ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32	Nov 05, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K912825	MAGNESIUM ASSAY KIT, CAT.# 100-12	Jul 26, 1991	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K912321	MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK	Jun 17, 1991	Substantially Equivalent	Nova Biomedical Corp.
K905544	MAGNESIUM REAGENT	Dec 27, 1990	Substantially Equivalent	Amresco, Inc.
K903306	TECHNICON CHEM I SYSTEM MAGNESIUM METHOD	Aug 29, 1990	Substantially Equivalent	Technicon Instruments Corp.
K903341	MAGNESIUM	Aug 22, 1990	Substantially Equivalent	Catachem, Inc.
K902919	SYNERMED MAGNESIUM REAGENT KIT	Jul 31, 1990	Substantially Equivalent	Synermed, Inc.
K901758	ROCHE REAGENT FOR MAGNESIUM	May 23, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K901124	CHEM I CLINICAL ANALYZER URINE MAGNESIUM	May 14, 1990	Substantially Equivalent	Technicon Instruments Corp.
K901265	COULTER MAGNESIUM REAGENT	Mar 29, 1990	Substantially Equivalent	Coulter Corp.
K894508	MAGNESIUM TEST ITEM NUMBER: 65419	Aug 31, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K890798	REVISED MAGNESIUM TEST ITEM NUMBER: SR1019	Mar 31, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K891355	MAGNESIUM REAGENT	Mar 28, 1989	Substantially Equivalent	Medical Analysis Systems, Inc.
K883170	STANBIO MAGNESIUM TEST SET, CAT. NO 0130	Feb 07, 1989	Substantially Equivalent	Stanbio Laboratory
K883967	BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD	Jan 27, 1989	Substantially Equivalent	Beckman Instruments, Inc.
K884600	TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM	Jan 23, 1989	Substantially Equivalent	Technicon Instruments Corp.
K885022	MAGNESIUM TEST ITEM NUMBER: SR1019	Jan 17, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K883972	MAGNESIUM REAGENT (MAGON SULFONATE)	Nov 10, 1988	Substantially Equivalent	Sigma Chemical Co.
K883326	TECHNICON RA(TM) SYSTEMS - MAGNESIUM	Oct 13, 1988	Substantially Equivalent	Technicon Instruments Corp.
K882256	MAGNESIUM REAGENT SET	Aug 08, 1988	Substantially Equivalent	Tech-Neal Scientific, Inc.
K880880	RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC	May 27, 1988	Substantially Equivalent	Reagents Applications, Inc.
K881300	MAGNESIUM LIQUID STABLE REAGENT SET	May 17, 1988	Substantially Equivalent	Medical Analysis Systems, Inc.
K874506	USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R)	Jan 22, 1988	Substantially Equivalent	Technicon Instruments Corp.
K874822	RAICHEM(TM) MAGNESIUM REAGENT	Jan 21, 1988	Substantially Equivalent	Reagents Applications, Inc.
K874595	MULTICHEM (R) MAGNESIUM REAGENT	Jan 21, 1988	Substantially Equivalent	Simmler, Inc.
K874576	KODAK EKTACHEM DT SLIDES (MG)	Jan 21, 1988	Substantially Equivalent	Eastman Kodak Company
K874847	MAGNESIUM	Dec 18, 1987	Substantially Equivalent	Tech-Co, Inc.
K873530	PARAMAX MAGNESIUM REAGENT	Dec 14, 1987	Substantially Equivalent	Baxter Healthcare Corp
K873180	BIOTROL MAGNESIUM CALMAGITE	Sep 02, 1987	Substantially Equivalent	Biotrol, USA, Inc.
K870370	MAGNESIUM REAGENT - CALMAGITE METHOD	Aug 19, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K872311	ABBOTT A-GENT LIQUID MAGNESIUM REAGENT	Jul 09, 1987	Substantially Equivalent	Abbott Laboratories
K870553	EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX	Mar 06, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K863069	MAGNESIOMETER	Dec 31, 1986	Substantially Equivalent	J. D. Assoc.
K861386	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG)	Aug 26, 1986	Substantially Equivalent	Eastman Kodak Company
K863002	EMDS(TM) MAGNESIUM TESTPACKS, #67671/95	Aug 19, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K861668	MAGNESIUM PROCEDURE	May 27, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K855190	MAGNESIUM REAGENT SET	Feb 18, 1986	Substantially Equivalent	Technostics Intl.
K860215	MAGNESIUM REAGENT SET	Feb 11, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K853853	TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC	Oct 03, 1985	Substantially Equivalent	Technicon Instruments Corp.
K853592	MAGNESIUM	Sep 16, 1985	Substantially Equivalent	Pointe Scientific, Inc.,
K852005	MG REAGENT	Jun 25, 1985	Substantially Equivalent	Alpkem Corp.
K851657	DEMAND MAGNESIUM	May 10, 1985	Substantially Equivalent	Cooper Biomedical, Inc.
K850381	MAGNESIUM REAGENT FOR DEMAND ANALYZER	Mar 01, 1985	Substantially Equivalent	Advanced Biomedical Methods, Inc.
K844278	DATA-CHEM MAGNESIUM	Jan 08, 1985	Substantially Equivalent	Data Medical Associates, Inc.
K843893	MAGNESIUM REAGENT SET	Oct 30, 1984	Substantially Equivalent	Livonia Diagnostics, Inc.
K843031	MAGNESIUM ASSAY KIT	Aug 27, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K841259	DETERMINATION OF MAGNESIUM IN SERUM OR	May 07, 1984	Substantially Equivalent	Sigma Chemical Co.
K840784	PARAMAX MAGNESIUM REAGENT	Apr 13, 1984	Substantially Equivalent	American Dade
K834075	MAGNESIUM B TEST	Feb 03, 1984	Substantially Equivalent	Wako Chemicals USA, Inc.
K821102	MEGNESIUM REAGENT KIT	May 05, 1982	Substantially Equivalent	Anco Medical Reagents & Assoc.
K820976	GIL CHEM MAGNESIUM REAGENT	Apr 26, 1982	Substantially Equivalent	Gilford Diagnostics
K810084	MAGNESIUM KIT	Jan 26, 1981	Substantially Equivalent	Bio-Analytics Laboratories, Inc.
K803088	MAGNESIUM TEST KIT	Jan 02, 1981	Substantially Equivalent	Mallinckrodt Critical Care
K802091	AMERICAN MONITOR MAGNESIUM #'S 1036&4021	Oct 10, 1980	Substantially Equivalent	American Monitor Corp.
K800327	MAGNESIUM REAGENT	Mar 25, 1980	Substantially Equivalent	Alta Diagnostics, Inc.
K792399	ELVI MAGNESIUM	Dec 07, 1979	Substantially Equivalent	Volu Sol Medical Industries
K771469	MULTISTAT III MAGNESIUM TEST	Sep 12, 1977	Substantially Equivalent	Instrumentation Laboratory CO