ClearanceBrief
Panels › Clinical Chemistry › Product code CFR · Class 2

Hexokinase, Glucose

Regulation 862.1345

1510(k)s in 12 months (145 all time)
0recalls in 12 months (22 all time)
21recalls that name a 510(k)
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Top companies in CFR

Company510(k)sRecalls
Pointe Scientific, Inc.,415
Em Diagnostic Systems, Inc.70
Roche Diagnostics61
Abbott Laboratories60
Harleco60
Heraeus Kulzer, Inc.60
Data Medical Associates, Inc.40
Diagnostic Chemicals , Ltd.40
Siemens Healthcare Diagnostics22
Bayer Corp.30
DateFirm and productCodeLinked 510(k)
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 CFRK061655
Jun 29, 2017Siemens Healthcare Diagnostics, Inc.
Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Terminated		 CFRNone listed
Feb 2, 2016Horiba Instruments Inc
ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorim
Terminated		 CFRK052007
Dec 18, 2014JAS Diagnostics Inc.
Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
Terminated		 CFRK011900
Mar 22, 2013Mindray DS USA, Inc. d.b.a. Mindray North America
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Terminated		 CFRK022519
K072018
Nov 4, 2009Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and
Terminated		 CFRK971754
Oct 31, 2008Pointe Scientific, Inc.
Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)
Terminated		 CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
Terminated		 CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG920-1200, HG920-2500 and 12-HG920-144. (Clinical chemistry)
Terminated		 CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (Clinical chemistry)
Terminated		 CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry)
Terminated		 CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R1. (Clinical chemistry)
Terminated		 CFRK002199
Sep 21, 2008Beckman Coulter Inc
Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
Terminated		 CFRK060256
Aug 3, 2006Pointe Scientific, Inc.
Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R2, 7-HG920-R2-17, 7-HG920-R2-200 and 7-HG920-R2-300.
Terminated		 CFRK002199
Aug 3, 2006Pointe Scientific, Inc.
Glucose HEX R1 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R1, 7-HG920-R1-67, 7-HG920-R1-600 and 7-HG920-R1-800.
Terminated		 CFRK002199
Aug 3, 2006Pointe Scientific, Inc.
Glucose HEX reagent sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L.
Terminated		 CFRK002199
Aug 3, 2006Pointe Scientific, Inc.
Glucose Hex reagent, sold by Pointe Scientific; in vitro diagnostic, Catalog no. 3-HG920-L .
Terminated		 CFRK002199
Aug 3, 2006Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, for the quantitative determination of glucose in serum, 10 x 100 ml R1, 10 x 20 ml R2 glucose reagent, or 1 x 2 L R1 x 500 ml R2, for use with Hita
Terminated		 CFRK002199
Aug 3, 2006Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the quantitative determination of glucose in serum, 10 x 5 ml R1 and 5 x 20 ml R2, or 9 x 67 ml R1and 9 x 17 ml R2 glucose reagent, for use with
Terminated		 CFRK002199
Aug 3, 2006Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R2 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog nu
Terminated		 CFRK002199
Aug 3, 2006Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 ml R1 glucose HEX, for use with Hitachi analyzer; in vitro diagnostic, Catalog nu
Terminated		 CFRK002199
May 25, 2006Roche Diagnostics Corp.
Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic.
Terminated		 CFRK854025

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