JGJ · Photometric Method, Magnesium
Clinical Chemistry · 21 CFR 862.1495 · Class 1
Overview
| Product Code | JGJ |
|---|---|
| Device Name | Photometric Method, Magnesium |
| Regulation | 21 CFR 862.1495 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
Classification Rationale
Class I.
Recent Cleared Devices (20 of 90)
Showing 20 most recent of 90 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K181748 | Magnesium | Abbott Laboratories | Sep 12, 2018 | SESE |
| K173294 | Magnesium | Abbott Laboratories | May 18, 2018 | SESE |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | Randox Laboratories, Ltd. | Apr 28, 2017 | SESE |
| K162399 | Atellica CH Magnesium (Mg) | Siemens Healthcare Diagnostics, Inc. | Jan 19, 2017 | SESE |
| K122302 | ACE MAGNESIUM REGENT | Alfa Wassermann Diagnostics Technologies, LLC | Aug 27, 2012 | SESE |
| K111915 | MAGNESIUM ASSAY | Sekisui Diagnostics P.E.I., Inc. | Dec 2, 2011 | SESE |
| K092737 | EASYRA MG REAGENT, MODEL 10220 | Medica Corp. | Nov 17, 2009 | SESE |
| K091910 | PICCOLO MAGNESIUM TEST SYSTEM | Abaxis, Inc. | Oct 1, 2009 | SESE |
| K063208 | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 | Diagnostic Chemicals , Ltd. | Jan 19, 2007 | SESE |
| K040508 | VITALAB MAGNESIUM REAGENT | Clinical Data, Inc. | Mar 8, 2004 | SESE |
| K040115 | PICCOLO MAGNESIUM TEST SYSTEM | Abaxis, Inc. | Jan 30, 2004 | SESE |
| K030010 | ATAC PAK MAGNESIUM REAGENT | Elan Diagnostics | Mar 10, 2003 | SESE |
| K012326 | WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 | Wiener Laboratories Saic | Nov 8, 2001 | SESE |
| K003835 | JAS MAGNESIUM REAGENT | Jas Diagnostics, Inc. | Mar 23, 2001 | SESE |
| K991761 | MAGNESIUM PRODUCT NO'S, 112-01, 112-02 | A.P. Total Care, Inc. | Sep 2, 1999 | SESE |
| K991717 | CARESIDE MG | Careside, Inc. | Aug 10, 1999 | SESE |
| K981791 | MG | Abbott Laboratories | Oct 23, 1998 | SESE |
| K983416 | ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 | Boehringer Mannheim Corp. | Oct 21, 1998 | SESE |
| K981192 | MG | Abbott Laboratories | May 1, 1998 | SESE |
| K974606 | RANDOX MAGNESIUM | Randox Laboratories, Ltd. | Feb 12, 1998 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 7 clearances
- Abbott Laboratories — 6 clearances
- Technicon Instruments Corp. — 6 clearances
- Abaxis, Inc. — 2 clearances
- Biotrol, USA, Inc. — 2 clearances
