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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)
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Top companies in JGJ

Company510(k)sRecalls
Abbott Laboratories61
Em Diagnostic Systems, Inc.70
Siemens Healthcare Diagnostics, Inc.15
Technicon Instruments Corp.60
Randox Laboratories, Ltd.23
Diagnostic Chemicals , Ltd.30
Abaxis, Inc.20
Biotrol, USA, Inc.20
Data Medical Associates, Inc.20
Eastman Kodak Company20
DateFirm and productCodeLinked 510(k)
Dec 26, 2024Siemens Healthcare Diagnostics, Inc.
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;
Open, Classified		 JGJK140790
Sep 26, 2022Siemens Healthcare Diagnostics, Inc.
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
Open, Classified		 JGJK861700
Jan 28, 2022Siemens 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		 JGJK140790
Dec 8, 2021Beckman Coulter Inc.
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Terminated		 JGJK944407
Nov 13, 2020Randox 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		 JGJK162200
Nov 13, 2020Randox Laboratories Ltd.
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Terminated		 JGJK974606
Jan 2, 2019Abbott 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		 JGJK981791
Apr 14, 2016Randox Laboratories, Limited
Magnesium on RX Imola analyser IVD
Terminated		 JGJK052914
Nov 25, 2015Siemens 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		 JGJK061655
Sep 24, 2014Horiba 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		 JGJK060205
Nov 15, 2013Ortho-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		 JGJK023876
K861386
Apr 17, 2012Siemens 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		 JGJK061655
Jan 16, 2004Abbott Laboratories Diagnostic Div
Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
Terminated		 JGJNone listed

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