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Panels › Clinical Chemistry › Product code CFJ · Class 2

Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Regulation 862.1440

0510(k)s in 12 months (111 all time)
0recalls in 12 months (8 all time)
4recalls that name a 510(k)
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Top companies in CFJ

Company510(k)sRecalls
Em Diagnostic Systems, Inc.100
Beckman Instruments, Inc.40
Diagnostic Chemicals , Ltd.40
Harleco40
J.T. Baker Chemical Co.40
Boehringer Mannheim Corp.30
Data Medical Associates, Inc.30
Gilford Diagnostics30
Pointe Scientific, Inc.,30
Randox Laboratories, Ltd.12
DateFirm and productCodeLinked 510(k)
Aug 11, 2020Randox Laboratories Ltd.
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. This pro
Terminated		 CFJK970684
Aug 11, 2020Randox Laboratories Ltd.
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum and plasma. T
Terminated		 CFJK970684
Oct 11, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vis
Terminated		 CFJNone listed
May 26, 2017Medtest Holdings, Inc.
Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
Terminated		 CFJK973589
Apr 3, 2017Beckman Coulter Inc.
Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).
Terminated		 CFJNone listed
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Assay: Lactate
Terminated		 CFJNone listed
Jun 27, 2015Roche Diagnostics Operations, Inc.
Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plas
Terminated		 CFJK964457
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) con
Terminated		 CFJNone listed

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