Panels › Clinical Chemistry › Product code JQP · Class 1
Calculator/Data Processing Module, For Clinical Use
Regulation 862.2100
0510(k)s in 12 months (78 all time)
2recalls in 12 months (218 all time)
17recalls that name a 510(k)
Top companies in JQP
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2009 | Abbott Laboratories, Inc ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy. Terminated |
JQP | None listed |
| Aug 25, 2009 | Perkin Elmer Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310.
The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and manageme Terminated |
JQP | None listed |
| Aug 25, 2009 | Perkin Elmer Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3.
The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow Terminated |
JQP | None listed |
| May 20, 2009 | Roche Diagnostics Corp. Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Server as follows: v.8.04.02.10, catalog no. 04785568001; v.8.04.03.01, catalog Terminated |
JQP | None listed |
| May 20, 2009 | Roche Diagnostics Corp. Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middleware Solutions Instrument Manager Standard as follows: v.8.04.02.10, catalog no. 04785550001; v.8.04.03, catalog Terminated |
JQP | None listed |
| May 15, 2009 | GE Healthcare Integrated IT Solutions Centricity TriWin Laboratory Information System; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
The Centricity TriWin Laboratory product is a laboratory information system. It is design Terminated |
JQP | None listed |
| May 1, 2009 | Cerner Corp Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions 3.4.0, 3.4.1 and 3.4.2. Terminated |
JQP | None listed |
| Feb 5, 2009 | Abbott Laboratories, Inc ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy. Terminated |
JQP | None listed |
| Dec 31, 2008 | GE Healthcare Integrated IT Solutions GE Centricity Ultra Laboratory System Software; for recording, reporting and distribution of lab results. GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Terminated |
JQP | None listed |
| Nov 12, 2008 | Sunquest Information Systems, Inc. Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.
The system is marketed as an automated solution for managing laboratory processes including: 1) Patie Terminated |
JQP | None listed |
| Oct 31, 2008 | Sunquest Information Systems, Inc. Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3.
Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection managem Terminated |
JQP | None listed |
| Sep 22, 2008 | SCC Soft Computer Product is SoftPath ASCII Software Releases 1.2, 2.1, 2.2, and 2.3. Terminated |
JQP | None listed |
| Sep 22, 2008 | SCC Soft Computer SoftPath GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for receiving accessing specimen reports, billing and management reports for surgical, GYN, NON-GYN and Autopsy cases Terminated |
JQP | None listed |
| Jan 25, 2008 | Abbott Laboratories, Inc Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL Terminated |
JQP | None listed |
| Nov 24, 2007 | Abbott Laboratories, Inc Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064 Terminated |
JQP | None listed |
| Jul 3, 2007 | Abbott Laboratories, Inc ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy. Terminated |
JQP | None listed |
| Jan 9, 2007 | Beckman Coulter Inc Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers Terminated |
JQP | None listed |
| Nov 29, 2006 | Data Innovations, Inc. Roche Cobas driver (rchcob6i), analytical laboratory data interface. Terminated |
JQP | None listed |
| Nov 29, 2006 | Data Innovations, Inc. Roche Modular Drive (rchmdlri), analytical laboratory data interface. Terminated |
JQP | None listed |
| Nov 14, 2006 | Data Innovations, Inc. Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R) Terminated |
JQP | None listed |
| Oct 28, 2006 | Radiometer America Inc Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer Terminated |
JQP | K050869 |
| Oct 27, 2006 | Ortho-Clinical Diagnostics VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" develope Terminated |
JQP | None listed |
| Jul 27, 2006 | Radiometer America Inc Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic. Terminated |
JQP | None listed |
| Jul 27, 2006 | SCC Soft Computer Product is SoftPath ASCII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinicial documentation and data processing. Terminated |
JQP | None listed |
| Jul 26, 2006 | SCC Soft Computer SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3 Terminated |
JQP | None listed |
| Dec 23, 2005 | Olympus America, Inc OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympu Terminated |
JQP | None listed |
| Oct 22, 2005 | Misys Healthcare Systems Misys Laboratory version 6.1 - Microbiology Module Terminated |
JQP | None listed |
| Aug 16, 2005 | Beckman Coulter Inc DL 2000 Data Manager Terminated |
JQP | None listed |
| Aug 10, 2005 | Beckman Coulter Inc Aqueduct Hematology Workflow Manager, software Terminated |
JQP | None listed |
| Jun 28, 2005 | Misys Healthcare Systems Mysis Laboratory version 6.1 Terminated |
JQP | None listed |
| Jun 28, 2005 | Misys Healthcare Systems Misys Laboratory with Lab Access Results application for versions 5.3 and later. Terminated |
JQP | None listed |
| Nov 30, 2004 | Beckman Coulter Inc DL2000 Data Manager Software, Version 6.4.108 Terminated |
JQP | None listed |
| Jul 20, 2004 | Misys Healthcare Systems Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results. Terminated |
JQP | None listed |
| Jul 20, 2004 | Abbott Laboratories, Inc AEROSET System Software version 1.02ER000 Terminated |
JQP | K980367 |
| Jul 20, 2004 | Misys Healthcare Systems Calculator/Data Processing Module for Clinical Use Terminated |
JQP | None listed |
| Jul 20, 2004 | Misys Healthcare Systems Misys Laboratory System, Versions 5.2, 5.23, 5.3 up to 5.3.2. Terminated |
JQP | None listed |
| Dec 24, 2003 | Abbott Laboratories, Inc The ARCHITECT c8000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas Terminated |
JQP | K980367 |
| Dec 24, 2003 | Abbott Laboratories, Inc The ARCHITECT i2000, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas Terminated |
JQP | K983212 |
| Dec 18, 2003 | Misys Healthcare Systems Calculator/ Data Processing Module for Clinical Use. Terminated |
JQP | None listed |
| Nov 6, 2003 | Beckman Coulter Inc Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems. Terminated |
JQP | K011213 K014034 +2 |
| Oct 24, 2003 | Beckman Coulter Inc Synchron CX4, CX5 and CX9 Pro Systems. Terminated |
JQP | K011465 K951189 |
| Oct 15, 2003 | Misys Healthcare Systems Calculator/ Data Processing Module for Clinical Use Terminated |
JQP | None listed |
| Sep 11, 2003 | Misys Healthcare Systems Calculator/ Data Processing Module for Clinical Use Terminated |
JQP | None listed |
| Sep 11, 2003 | Misys Healthcare Systems Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results Terminated |
JQP | None listed |
| Aug 7, 2003 | Misys Healthcare Systems Misys Laboratory System version 5.3 Terminated |
JQP | None listed |
| Aug 7, 2003 | Misys Healthcare Systems Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation. Terminated |
JQP | None listed |
| Aug 7, 2003 | Misys Healthcare Systems Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module Terminated |
JQP | None listed |
| Jul 23, 2003 | Roche Diagnostics Corp. MagNA Pure LC Instrument; Catalog number 2236931. Terminated |
JQP | None listed |
| Jul 15, 2003 | Misys Healthcare Systems Misys Laboratory System, versions 5.2, 5.23 and 5.3 Terminated |
JQP | None listed |
| Jul 2, 2003 | Misys Healthcare Systems Mysys Laboratory System Version 5.3 Terminated |
JQP | None listed |
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