Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JGJ — Predicate Candidate Screening
90 FDA 510(k) clearances under this product code; the 50 most recent screened below.
50 daysmedian FDA review time
141 days90th percentile
90clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181748 | Magnesium | Abbott Laboratories | 2018-09-12 | 72 | 0 |
| K173294 | Magnesium | Abbott Laboratories | 2018-05-18 | 214 | 0 |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | Randox Laboratories, Ltd. | 2017-04-28 | 266 | 0 |
| K162399 | Atellica CH Magnesium (Mg) | Siemens Healthcare Diagnostics, Inc. | 2017-01-19 | 146 | 0 |
| K122302 | ACE MAGNESIUM REGENT | Alfa Wassermann Diagnostics Technologies, LLC | 2012-08-27 | 26 | 0 |
| K111915 | MAGNESIUM ASSAY | Sekisui Diagnostics P.E.I., Inc. | 2011-12-02 | 149 | 0 |
| K092737 | EASYRA MG REAGENT, MODEL 10220 | Medica Corp. | 2009-11-17 | 70 | 0 |
| K091910 | PICCOLO MAGNESIUM TEST SYSTEM | Abaxis, Inc. | 2009-10-01 | 98 | 0 |
| K063208 | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 | Diagnostic Chemicals , Ltd. | 2007-01-19 | 88 | 0 |
| K040508 | VITALAB MAGNESIUM REAGENT | Clinical Data, Inc. | 2004-03-08 | 10 | 0 |
| K040115 | PICCOLO MAGNESIUM TEST SYSTEM | Abaxis, Inc. | 2004-01-30 | 10 | 0 |
| K030010 | ATAC PAK MAGNESIUM REAGENT | Elan Diagnostics | 2003-03-10 | 67 | 0 |
| K012326 | WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 | Wiener Laboratories Saic | 2001-11-08 | 108 | 0 |
| K003835 | JAS MAGNESIUM REAGENT | Jas Diagnostics, Inc. | 2001-03-23 | 101 | 0 |
| K991761 | MAGNESIUM PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | 1999-09-02 | 101 | 0 |
| K991717 | CARESIDE MG | Careside, Inc. | 1999-08-10 | 82 | 0 |
| K981791 | MG | Abbott Laboratories | 1998-10-23 | 155 | 0 |
| K983416 | ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 | Boehringer Mannheim Corp. | 1998-10-21 | 22 | 0 |
| K981192 | MG | Abbott Laboratories | 1998-05-01 | 29 | 0 |
| K974606 | RANDOX MAGNESIUM | Randox Laboratories, Ltd. | 1998-02-12 | 64 | 0 |
| K964915 | MAGNESIUM | Derma Media Lab., Inc. | 1997-03-26 | 107 | 0 |
| K952426 | MAGNESIUM REAGENT | Schiapparelli Biosystems, Inc. | 1995-08-07 | 75 | 0 |
| K943001 | MAGNESIUM QVET | Prisma Systems | 1994-12-29 | 189 | 0 |
| K944407 | OLYMPUS MAGNESIUM REAGENT | Olympus America, Inc. | 1994-12-27 | 110 | 0 |
| K944202 | ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED | Abbott Laboratories | 1994-11-14 | 95 | 0 |
| K935183 | EMDS MAGNESIUM (MG) TEST | Em Diagnostic Systems, Inc. | 1993-12-09 | 43 | 0 |
| K930074 | IN-VITRO DIAGNOSTIC REAGENT SET | Horizon Diagnostics, Inc. | 1993-05-11 | 124 | 0 |
| K926144 | URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS | Heraeus Kulzer, Inc. | 1993-01-27 | 51 | 0 |
| K924658 | OLYMPUS MAGNESIUM REAGENT | Olympus Corp. | 1992-10-19 | 34 | 0 |
| K923927 | KING DIAGNOSTICS MAGNESIUM REAGENT | King Diagnostics, Inc. | 1992-09-30 | 56 | 0 |
| K923411 | OLYMPUS MAGNESIUM REAGENT | Olympus Corp. | 1992-08-18 | 39 | 0 |
| K921677 | BIOTROL MAGNESIUM (MAGON) | Biotrol, USA, Inc. | 1992-05-26 | 48 | 0 |
| K920603 | TRACE MAGNESIUM - ARSENAZO REAGENT | Trace America, Inc. | 1992-03-11 | 39 | 0 |
| K913764 | ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 | Em Diagnostic Systems, Inc. | 1991-11-05 | 75 | 0 |
| K912825 | MAGNESIUM ASSAY KIT, CAT.# 100-12 | Diagnostic Chemicals, Ltd. (Usa) | 1991-07-26 | 30 | 0 |
| K912321 | MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK | Nova Biomedical Corp. | 1991-06-17 | 24 | 0 |
| K905544 | MAGNESIUM REAGENT | Amresco, Inc. | 1990-12-27 | 16 | 0 |
| K903306 | TECHNICON CHEM I SYSTEM MAGNESIUM METHOD | Technicon Instruments Corp. | 1990-08-29 | 36 | 0 |
| K903341 | MAGNESIUM | Catachem, Inc. | 1990-08-22 | 28 | 0 |
| K902919 | SYNERMED MAGNESIUM REAGENT KIT | Synermed, Inc. | 1990-07-31 | 28 | 0 |
| K901758 | ROCHE REAGENT FOR MAGNESIUM | Roche Diagnostic Systems, Inc. | 1990-05-23 | 35 | 0 |
| K901124 | CHEM I CLINICAL ANALYZER URINE MAGNESIUM | Technicon Instruments Corp. | 1990-05-14 | 63 | 0 |
| K901265 | COULTER MAGNESIUM REAGENT | Coulter Corp. | 1990-03-29 | 13 | 0 |
| K894508 | MAGNESIUM TEST ITEM NUMBER: 65419 | Em Diagnostic Systems, Inc. | 1989-08-31 | 43 | 0 |
| K890798 | REVISED MAGNESIUM TEST ITEM NUMBER: SR1019 | Em Diagnostic Systems, Inc. | 1989-03-31 | 42 | 0 |
| K891355 | MAGNESIUM REAGENT | Medical Analysis Systems, Inc. | 1989-03-28 | 18 | 0 |
| K883170 | STANBIO MAGNESIUM TEST SET, CAT. NO 0130 | Stanbio Laboratory | 1989-02-07 | 195 | 0 |
| K883967 | BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD | Beckman Instruments, Inc. | 1989-01-27 | 129 | 0 |
| K884600 | TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM | Technicon Instruments Corp. | 1989-01-23 | 81 | 0 |
| K885022 | MAGNESIUM TEST ITEM NUMBER: SR1019 | Em Diagnostic Systems, Inc. | 1989-01-17 | 43 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda