Atlas FDA

JGJ

90 FDA 510(k) clearances · Product code

50 daysmedian time to decision
141 days90th percentile
90clearances measured

FDA profile

Official device name
Photometric Method, Magnesium
Device class
Class I (low risk)
Regulation
21 CFR 862.1495
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 33 · 2022: 42 · 2023: 31 · 2024: 17 · 2025: 22 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Magnesium (K181748)Abbott Laboratories2018-09-12
Magnesium (K173294)Abbott Laboratories2018-05-18
Randox RX Daytona Plus Magnesium (MG) (K162200)Randox Laboratories, Ltd.2017-04-28
Atellica CH Magnesium (Mg) (K162399)Siemens Healthcare Diagnostics, Inc.2017-01-19
ACE MAGNESIUM REGENT (K122302)Alfa Wassermann Diagnostics Technologies, LLC2012-08-27
MAGNESIUM ASSAY (K111915)Sekisui Diagnostics P.E.I., Inc.2011-12-02
EASYRA MG REAGENT, MODEL 10220 (K092737)Medica Corp.2009-11-17
PICCOLO MAGNESIUM TEST SYSTEM (K091910)Abaxis, Inc.2009-10-01
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 (K063208)Diagnostic Chemicals , Ltd.2007-01-19
VITALAB MAGNESIUM REAGENT (K040508)Clinical Data, Inc.2004-03-08
PICCOLO MAGNESIUM TEST SYSTEM (K040115)Abaxis, Inc.2004-01-30
ATAC PAK MAGNESIUM REAGENT (K030010)Elan Diagnostics2003-03-10
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 (K012326)Wiener Laboratories Saic2001-11-08
JAS MAGNESIUM REAGENT (K003835)Jas Diagnostics, Inc.2001-03-23
MAGNESIUM PRODUCT NO'S, 112-01, 112-02 (K991761)A.P. Total Care, Inc.1999-09-02
CARESIDE MG (K991717)Careside, Inc.1999-08-10
MG (K981791)Abbott Laboratories1998-10-23
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 (K983416)Boehringer Mannheim Corp.1998-10-21
MG (K981192)Abbott Laboratories1998-05-01
RANDOX MAGNESIUM (K974606)Randox Laboratories, Ltd.1998-02-12
MAGNESIUM (K964915)Derma Media Lab., Inc.1997-03-26
MAGNESIUM REAGENT (K952426)Schiapparelli Biosystems, Inc.1995-08-07
MAGNESIUM QVET (K943001)Prisma Systems1994-12-29
OLYMPUS MAGNESIUM REAGENT (K944407)Olympus America, Inc.1994-12-27
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED (K944202)Abbott Laboratories1994-11-14
EMDS MAGNESIUM (MG) TEST (K935183)Em Diagnostic Systems, Inc.1993-12-09
IN-VITRO DIAGNOSTIC REAGENT SET (K930074)Horizon Diagnostics, Inc.1993-05-11
URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS (K926144)Heraeus Kulzer, Inc.1993-01-27
OLYMPUS MAGNESIUM REAGENT (K924658)Olympus Corp.1992-10-19
KING DIAGNOSTICS MAGNESIUM REAGENT (K923927)King Diagnostics, Inc.1992-09-30
OLYMPUS MAGNESIUM REAGENT (K923411)Olympus Corp.1992-08-18
BIOTROL MAGNESIUM (MAGON) (K921677)Biotrol, USA, Inc.1992-05-26
TRACE MAGNESIUM - ARSENAZO REAGENT (K920603)Trace America, Inc.1992-03-11
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 (K913764)Em Diagnostic Systems, Inc.1991-11-05
MAGNESIUM ASSAY KIT, CAT.# 100-12 (K912825)Diagnostic Chemicals, Ltd. (Usa)1991-07-26
MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK (K912321)Nova Biomedical Corp.1991-06-17
MAGNESIUM REAGENT (K905544)Amresco, Inc.1990-12-27
TECHNICON CHEM I SYSTEM MAGNESIUM METHOD (K903306)Technicon Instruments Corp.1990-08-29
MAGNESIUM (K903341)Catachem, Inc.1990-08-22
SYNERMED MAGNESIUM REAGENT KIT (K902919)Synermed, Inc.1990-07-31
ROCHE REAGENT FOR MAGNESIUM (K901758)Roche Diagnostic Systems, Inc.1990-05-23
CHEM I CLINICAL ANALYZER URINE MAGNESIUM (K901124)Technicon Instruments Corp.1990-05-14
COULTER MAGNESIUM REAGENT (K901265)Coulter Corp.1990-03-29
MAGNESIUM TEST ITEM NUMBER: 65419 (K894508)Em Diagnostic Systems, Inc.1989-08-31
REVISED MAGNESIUM TEST ITEM NUMBER: SR1019 (K890798)Em Diagnostic Systems, Inc.1989-03-31
MAGNESIUM REAGENT (K891355)Medical Analysis Systems, Inc.1989-03-28
STANBIO MAGNESIUM TEST SET, CAT. NO 0130 (K883170)Stanbio Laboratory1989-02-07
BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD (K883967)Beckman Instruments, Inc.1989-01-27
TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM (K884600)Technicon Instruments Corp.1989-01-23
MAGNESIUM TEST ITEM NUMBER: SR1019 (K885022)Em Diagnostic Systems, Inc.1989-01-17
MAGNESIUM REAGENT (MAGON SULFONATE) (K883972)Sigma Chemical Co.1988-11-10
TECHNICON RA(TM) SYSTEMS - MAGNESIUM (K883326)Technicon Instruments Corp.1988-10-13
MAGNESIUM REAGENT SET (K882256)Tech-Neal Scientific, Inc.1988-08-08
RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC (K880880)Reagents Applications, Inc.1988-05-27
MAGNESIUM LIQUID STABLE REAGENT SET (K881300)Medical Analysis Systems, Inc.1988-05-17
USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R) (K874506)Technicon Instruments Corp.1988-01-22
MULTICHEM (R) MAGNESIUM REAGENT (K874595)Simmler, Inc.1988-01-21
RAICHEM(TM) MAGNESIUM REAGENT (K874822)Reagents Applications, Inc.1988-01-21
KODAK EKTACHEM DT SLIDES (MG) (K874576)Eastman Kodak Company1988-01-21
MAGNESIUM (K874847)Tech-Co, Inc.1987-12-18
PARAMAX MAGNESIUM REAGENT (K873530)Baxter Healthcare Corp1987-12-14
BIOTROL MAGNESIUM CALMAGITE (K873180)Biotrol, USA, Inc.1987-09-02
MAGNESIUM REAGENT - CALMAGITE METHOD (K870370)Trace Scientific , Ltd.1987-08-19
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT (K872311)Abbott Laboratories1987-07-09
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX (K870553)Em Diagnostic Systems, Inc.1987-03-06
MAGNESIOMETER (K863069)J. D. Assoc.1986-12-31
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG) (K861386)Eastman Kodak Company1986-08-26
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95 (K863002)Em Diagnostic Systems, Inc.1986-08-19
MAGNESIUM PROCEDURE (K861668)Data Medical Associates, Inc.1986-05-27
MAGNESIUM REAGENT SET (K855190)Technostics Intl.1986-02-18
MAGNESIUM REAGENT SET (K860215)Sterling Diagnostics, Inc.1986-02-11
TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC (K853853)Technicon Instruments Corp.1985-10-03
MAGNESIUM (K853592)Pointe Scientific, Inc.,1985-09-16
MG REAGENT (K852005)Alpkem Corp.1985-06-25
DEMAND MAGNESIUM (K851657)Cooper Biomedical, Inc.1985-05-10
MAGNESIUM REAGENT FOR DEMAND ANALYZER (K850381)Advanced Biomedical Methods, Inc.1985-03-01
DATA-CHEM MAGNESIUM (K844278)Data Medical Associates, Inc.1985-01-08
MAGNESIUM REAGENT SET (K843893)Livonia Diagnostics, Inc.1984-10-30
MAGNESIUM ASSAY KIT (K843031)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
DETERMINATION OF MAGNESIUM IN SERUM OR (K841259)Sigma Chemical Co.1984-05-07
PARAMAX MAGNESIUM REAGENT (K840784)American Dade1984-04-13
MAGNESIUM B TEST (K834075)Wako Chemicals USA, Inc.1984-02-03
MEGNESIUM REAGENT KIT (K821102)Anco Medical Reagents & Assoc.1982-05-05
GIL CHEM MAGNESIUM REAGENT (K820976)Gilford Diagnostics1982-04-26
MAGNESIUM KIT (K810084)Bio-Analytics Laboratories, Inc.1981-01-26
MAGNESIUM TEST KIT (K803088)Mallinckrodt Critical Care1981-01-02
AMERICAN MONITOR MAGNESIUM #'S 1036&4021 (K802091)American Monitor Corp.1980-10-10
MAGNESIUM REAGENT (K800327)Alta Diagnostics, Inc.1980-03-25
ELVI MAGNESIUM (K792399)Volu Sol Medical Industries1979-12-07
MULTISTAT III MAGNESIUM TEST (K771469)Instrumentation Laboratory CO1977-09-12

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