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Panels › Clinical Chemistry › Product code JIX · Class 2

Calibrator, Multi-Analyte Mixture

Regulation 862.1150

0510(k)s in 12 months (302 all time)
1recalls in 12 months (73 all time)
60recalls that name a 510(k)
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Top companies in JIX

Company510(k)sRecalls
Siemens Healthcare Diagnostics1220
Alko Diagnostic Corp.210
Dade Behring, Inc.180
Roche Diagnostics142
Ortho-Clinical Diagnostics, Inc.411
Randox Laboratories, Ltd.510
Bhp Diagnostix, Inc.110
Roche Diagnostic Systems, Inc.90
Beckman Instruments, Inc.80
Boehringer Mannheim Corp.80
DateFirm and productCodeLinked 510(k)
Sep 9, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and Triglycerides methods on the Dimension Vista system.
Terminated		 JIXK061703
May 4, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System
Terminated		 JIXK062334
Feb 26, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Cr
Terminated		 JIXK061838
Dec 1, 2009Cargille-Sacher Laboratories Inc.
Cargille Modified Kingsbury-Clark Albumin Standards For in vitro Diagnostics (Set of 8 Standards: 5, 10, 20, 30, 40, 50, 75, 100 mg/ml); Catalog number: 52064;
Terminated		 JIXNone listed
Feb 6, 2009Abbott Laboratories Inc.
Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator, List Number: 1E69-03, Lot Numbers: 54187M200 For use in the calibration of the Iron and Magnesium assays.
Terminated		 JIXK981706
Jan 12, 2009Abbott Laboratories Inc.
ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determ
Terminated		 JIXNone listed
Jan 6, 2009Roche Diagnostics Corp.
Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.
Terminated		 JIXK060373
Dec 29, 2007Roche Diagnostics Corp.
Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog No. 20751995190. Roche Diagnostics Corp
Terminated		 JIXK031880
Aug 10, 2007Abbott Laboratories Inc.
Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064
Terminated		 JIXK981706
Apr 14, 2007Mega Diagnostics
Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials.
Terminated		 JIXK882117
Apr 14, 2007Mega Diagnostics
Mega Diagnostics Ammonia/Alcohol Controls (Cat.# A7504-CTL) packaged in 5ml vials
Terminated		 JIXK972333
Feb 27, 2007Diagnostic Chemicals, Ltd.
Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252
Terminated		 JIXK042243
Sep 30, 2006Pointe Scientific, Inc.
Alcohol Standard sold by Pointe Scientific; Catalog # 7-A7504-STD.
Terminated		 JIXK882117
Sep 30, 2006Pointe Scientific, Inc.
Alcohol Control, Level 2 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L2.
Terminated		 JIXK972333
Sep 30, 2006Pointe Scientific, Inc.
Alcohol Control, Level 1 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L1.
Terminated		 JIXK972333
Sep 30, 2006Pointe Scientific, Inc.
Alcohol Control sold by Pointe Scientific; Catalog # 7-A7504-CTL.
Terminated		 JIXK972333
Sep 30, 2006Pointe Scientific, Inc.
Alcohol Standard, 100 mg/dl, Pointe Scientific Inc., Canton, MI; Catalog # A7504-STD.
Terminated		 JIXK882117
Sep 30, 2006Pointe Scientific, Inc.
Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum, Imported and marketed in India by Ranbaxy Laboratories Ltd., New Delhi; Catalog # A7504-150-S.
Terminated		 JIXNone listed
Sep 30, 2006Pointe Scientific, Inc.
Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL.
Terminated		 JIXK972333
Mar 23, 2006Alfa Wassermann, Inc
Gemcal Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control.
Terminated		 JIXK930104
Feb 14, 2006Abbott Laboratories Diagnostic Div
Clinical Chemistry Multiconstituent Calibrator--- List number: lE65-02
Terminated		 JIXK981706
Aug 24, 2005Abbott Laboratories Diagnostic Div
Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
Terminated		 JIXNone listed
Aug 17, 2004Beckman Coulter Inc
SYNCHRON Clinical Systems Enzyme Validator Kit
Terminated		 JIXK984014

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