Product code JGJ
- Device name
- Photometric Method, Magnesium
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1495
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181748 | Magnesium | Abbott Laboratories | 2018-09-12 |
| K173294 | Magnesium | Abbott Laboratories | 2018-05-18 |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | Randox Laboratories, Ltd. | 2017-04-28 |
| K162399 | Atellica CH Magnesium (Mg) | Siemens Healthcare Diagnostics, Inc. | 2017-01-19 |
| K122302 | ACE MAGNESIUM REGENT | Alfa Wassermann Diagnostics Technologies, LLC | 2012-08-27 |
| K111915 | MAGNESIUM ASSAY | Sekisui Diagnostics P.E.I., Inc. | 2011-12-02 |
| K092737 | EASYRA MG REAGENT, MODEL 10220 | Medica Corp. | 2009-11-17 |
| K091910 | PICCOLO MAGNESIUM TEST SYSTEM | Abaxis, Inc. | 2009-10-01 |
| K063208 | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 | Diagnostic Chemicals , Ltd. | 2007-01-19 |
| K040508 | VITALAB MAGNESIUM REAGENT | Clinical Data, Inc. | 2004-03-08 |
| K040115 | PICCOLO MAGNESIUM TEST SYSTEM | Abaxis, Inc. | 2004-01-30 |
| K030010 | ATAC PAK MAGNESIUM REAGENT | Elan Diagnostics | 2003-03-10 |
| K012326 | WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 | Wiener Laboratories Saic | 2001-11-08 |
| K003835 | JAS MAGNESIUM REAGENT | Jas Diagnostics, Inc. | 2001-03-23 |
| K991761 | MAGNESIUM PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | 1999-09-02 |
| K991717 | CARESIDE MG | Careside, Inc. | 1999-08-10 |
| K981791 | MG | Abbott Laboratories | 1998-10-23 |
| K983416 | ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 | Boehringer Mannheim Corp. | 1998-10-21 |
| K981192 | MG | Abbott Laboratories | 1998-05-01 |
| K974606 | RANDOX MAGNESIUM | Randox Laboratories, Ltd. | 1998-02-12 |
| K964915 | MAGNESIUM | Derma Media Lab., Inc. | 1997-03-26 |
| K952426 | MAGNESIUM REAGENT | Schiapparelli Biosystems, Inc. | 1995-08-07 |
| K943001 | MAGNESIUM QVET | Prisma Systems | 1994-12-29 |
| K944407 | OLYMPUS MAGNESIUM REAGENT | Olympus America, Inc. | 1994-12-27 |
| K944202 | ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED | Abbott Laboratories | 1994-11-14 |
| K935183 | EMDS MAGNESIUM (MG) TEST | Em Diagnostic Systems, Inc. | 1993-12-09 |
| K930074 | IN-VITRO DIAGNOSTIC REAGENT SET | Horizon Diagnostics, Inc. | 1993-05-11 |
| K926144 | URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS | Heraeus Kulzer, Inc. | 1993-01-27 |
| K924658 | OLYMPUS MAGNESIUM REAGENT | Olympus Corp. | 1992-10-19 |
| K923927 | KING DIAGNOSTICS MAGNESIUM REAGENT | King Diagnostics, Inc. | 1992-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10673486002096 | Teco Diagnostics Magnesium Reagent Set | TECO DIAGNOSTICS | 2023-11-14 |
| 10673486002126 | Teco Diagnostics Magnesium Reagent Kit for TC-Matrix | TECO DIAGNOSTICS | 2023-11-14 |
| 00817302024104 | CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024203 | CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024289 | CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT CC220 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024449 | CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT DT220 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024586 | CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT ST220 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00380740169855 | ARCHITECT | ABBOTT IRELAND | 2022-05-24 |
| 00380740169862 | ARCHITECT | ABBOTT IRELAND | 2022-05-24 |
| 00380740176532 | Alinity | ABBOTT IRELAND | 2021-12-27 |
| 00380740176525 | Alinity | ABBOTT IRELAND | 2021-12-27 |
| 04015630930821 | Magnesium Gen.2 | Roche Diagnostics GmbH | 2021-02-08 |
| 04015630926992 | Magnesium | Roche Diagnostics GmbH | 2021-02-08 |
| 04015630913381 | Magnesium | Roche Diagnostics GmbH | 2021-02-08 |
| 00811727016232 | Pointe Magnesium Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 00811727015938 | Pointe Magnesium Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 00630414595597 | Atellica CH Mg | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768014185 | Dimension® Flex® reagent cartridge MG | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00842768015694 | Dimension Vista® Flex® reagent cartridge MG | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 03610230007112 | Yumizen C1200 Magnesium | HORIBA ABX SAS | 2020-08-28 |
| 10758750000265 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-05-29 |
| 10758750004621 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-05-29 |
| 00380740121839 | Alinity | Abbott GmbH | 2019-02-12 |
| 00015482771195 | SPOTCHEM™ II Magnesium | ARKRAY USA, INC. | 2016-09-23 |
| 00015482771072 | SPOTCHEM™ II Calcium | ARKRAY USA, INC. | 2016-09-23 |
| 00015482771058 | SPOTCHEM™ II BUN | ARKRAY USA, INC. | 2016-09-23 |
| EABA40000371 | Piccolo MetLac 12 Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000311 | Piccolo Basic Metabolic Panel Plus | ABAXIS, INC. | 2016-09-23 |
| 04015630929818 | Magnesium Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 03610230005088 | ABX PENTRA MAGNESIUM RTU | HORIBA ABX SAS | 2016-08-23 |