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Panels › Clinical Toxicology › Product code DKJ · Class 2

Colorimetry, Salicylate

Regulation 862.3830

0510(k)s in 12 months (29 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in DKJ

DateFirm and productCodeLinked 510(k)
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
Terminated
DKJK093939
Apr 3, 2017Beckman Coulter Inc.
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
Terminated
DKJK014173
Sep 23, 2016Microgenics Corporation
DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
Terminated
DKJK961131
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/3
Terminated
DKJK902356
Sep 30, 2009Beckman Coulter Inc
SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON
Terminated
DKJK014173
Jan 23, 2007Diagnostic Chemicals, Ltd.
Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892
Terminated
DKJK042329
Feb 4, 2004Abbott Laboratories HPD/ADD/GPRD
TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Terminated
DKJK844070

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