Panels › Clinical Chemistry › Product code JGJ · Class 1
Photometric Method, Magnesium
Regulation 862.1495
0510(k)s in 12 months (90 all time)
0recalls in 12 months (13 all time)
12recalls that name a 510(k)
Top companies in JGJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 26, 2024 | Siemens Healthcare Diagnostics, Inc. Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158; Open, Classified |
JGJ | K140790 |
| Sep 26, 2022 | Siemens Healthcare Diagnostics, Inc. Dimension Magnesium (MG) Flex reagent cartridge
Siemens
Material Number (SMN)/REF (Catalog Number):10444963/DF57 Open, Classified |
JGJ | K861700 |
| Jan 28, 2022 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057 used in the Dimension Vista System.
The Dimension Vista Magnesium Flex Reagent (MG) method is an I Open, Classified |
JGJ | K140790 |
| Dec 8, 2021 | Beckman Coulter Inc. AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850 Terminated |
JGJ | K944407 |
| Nov 13, 2020 | Randox Laboratories Ltd. Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine
Catalogue Number: MG8326 Terminated |
JGJ | K162200 |
| Nov 13, 2020 | Randox Laboratories Ltd. Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine
Catalogue Number: MG3880 Terminated |
JGJ | K974606 |
| Jan 2, 2019 | Abbott Laboratories, Inc ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31
The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine. Terminated |
JGJ | K981791 |
| Apr 14, 2016 | Randox Laboratories, Limited Magnesium on RX Imola analyser
IVD Terminated |
JGJ | K052914 |
| Nov 25, 2015 | Siemens Healthcare Diagnostics, Inc. Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System. Terminated |
JGJ | K061655 |
| Sep 24, 2014 | Horiba Instruments, Inc dba Horiba Medical ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646
Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination o Terminated |
JGJ | K060205 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204
VITROS Mg Slides quantitatively measure magnesium (Mg) conc Terminated |
JGJ | K023876 K861386 |
| Apr 17, 2012 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) MG Flex(R) Reagent Cartridge
The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the D Terminated |
JGJ | K061655 |
| Jan 16, 2004 | Abbott Laboratories Diagnostic Div Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30. Terminated |
JGJ | None listed |
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