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Panels › Clinical Toxicology › Product code DKB · Class 2

Calibrators, Drug Mixture

Regulation 862.3200

0510(k)s in 12 months (94 all time)
0recalls in 12 months (9 all time)
7recalls that name a 510(k)
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Top companies in DKB

Company510(k)sRecalls
Syva Co.210
Roche Diagnostic Systems, Inc.100
Roche Diagnostics52
Diagnostic Reagents, Inc.60
Microgenics Corp.60
Dade Behring, Inc.50
Beckman Coulter, Inc.31
Lin-Zhi International, Inc.22
Boehringer Mannheim Corp.30
E.I. Dupont DE Nemours & Co., Inc.30
DateFirm and productCodeLinked 510(k)
Nov 10, 2022Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VI
Open, Classified		 DKBNone listed
Mar 8, 2022MEDLINE INDUSTRIES, LP - Northfield
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
Terminated		 DKBNone listed
Jun 16, 2014Ortho-Clinical Diagnostics
VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS
Terminated		 DKBK041799
K063164
Jan 10, 2013Siemens Healthcare Diagnostics, Inc.
Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a
Terminated		 DKBK790735
Mar 6, 2012Beckman Coulter Inc.
Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX
Terminated		 DKBK955644
Jan 25, 2012Lin-Zhi International Inc
Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphin
Terminated		 DKBK051088
Jan 25, 2012Lin-Zhi International Inc
Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug a
Terminated		 DKBK051088
Sep 10, 2009Roche Diagnostics Corp.
Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain d
Terminated		 DKBK031856
Sep 10, 2009Roche Diagnostics Corp.
Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain dr
Terminated		 DKBK031856

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