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) |
|---|---|---|---|
| Jan 18, 2018 | Beckman Coulter Inc. AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system. Terminated |
JQP | None listed |
| Nov 17, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version)
Specimen Gate Screening Center is used for data management of neonatal screenin Terminated |
JQP | None listed |
| Oct 16, 2017 | Normand Informatique Remisol Advance Software (Driver Architect) Catalog Number B32129
The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected Terminated |
JQP | None listed |
| Sep 12, 2017 | Abbott Point Of Care Inc. i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255) Terminated |
JQP | None listed |
| May 25, 2017 | Merge Healthcare, Inc. Merge LIS software. The firm name on the label is Merge Healthcare.
Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order e Terminated |
JQP | None listed |
| May 9, 2017 | Roche Diagnostics Corporation Cobas connection module (CCM) - OUTPUT UNIT
The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi Terminated |
JQP | None listed |
| Mar 23, 2017 | Roche Diagnostics Corporation Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Terminated |
JQP | None listed |
| Mar 23, 2017 | Roche Diagnostics Corporation Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx Terminated |
JQP | None listed |
| Mar 13, 2017 | PerkinElmer Life and Analytical Sciences, Wallac, OY Specimen Gate Laboratory; Product Number: 5002-0180
Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Terminated |
JQP | None listed |
| Feb 27, 2017 | Becton Dickinson & Co. EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System .
Product Usage:
The EpiCenter system is a clinical data management Terminated |
JQP | None listed |
| Feb 16, 2017 | Data Innovations, LLC JResultNet drivers using ASTM coding language.
Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and Terminated |
JQP | None listed |
| Jan 24, 2017 | Roche Diagnostics Corporation cobas p 612 pre-analytical system;
Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis. Terminated |
JQP | None listed |
| Jan 18, 2017 | Beckman Coulter Inc. AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550.
AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and p Terminated |
JQP | None listed |
| Dec 23, 2016 | PerkinElmer Health Sciences, Inc. Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0
Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, a Terminated |
JQP | None listed |
| Nov 29, 2016 | Siemens Healthcare Diagnostics, Inc. CentraLink Data Management System Software Versions: v13x,v14x,v15x
The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. cobas p 312 Pre-Analytical System
calculator/data processing module, for clinical use
Product Usage:
The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, wh Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. cobas p 471 centrifuge unit
calculator/data processing module, for clinical use
Product Usage:
The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decappi Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. cobas p 512 Pre-Analytical Instrument
calculator/data processing module, for clinical use
Product Usage:
The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Cha Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. cobas p 612 Pre-Analytical Instrument
calculator/data processing module, for clinical use
Product Usage:
The cobas 6000 series is a fully automated, random-access, software-controlled system for immu Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. RSD 800 Sorting System
calculator/data processing module, for clinical use
Product Usage:
The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intended f Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. RSD 800A Aliquoting System
calculator/data processing module, for clinical use
Product Usage:
The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled syste Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. VS II Aliquoter System
calculator/data processing module, for clinical use
Product Usage:
Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quantita Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. cobas p 501 Post-Analytical Unit
calculator/data processing module, for clinical use
Product Usage:
The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including c Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. cobas p 701 Post-Analytical Unit
calculator/data processing module, for clinical use
Product Usage:
The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative o Terminated |
JQP | None listed |
| Jul 15, 2016 | Roche Diagnostics Operations, Inc. Modular Pre Analytics ( EVO/Plus)
Product Usage:
The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar cod Terminated |
JQP | None listed |
| Feb 23, 2016 | Roche Diagnostics Operations, Inc. cobas p 512 pre-analytical system
Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. Terminated |
JQP | None listed |
| Nov 18, 2015 | Roche Diagnostics Operations, Inc. Bulk Loader Module for cobas p 512/612
Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component. Terminated |
JQP | None listed |
| Nov 3, 2015 | bioMerieux, Inc. MYLA CLI V3.X TO V4.1 ML350 SERVER
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and th Terminated |
JQP | None listed |
| Nov 3, 2015 | bioMerieux, Inc. MYLA CLI V3.X TO V4.1 DL380 SERVER
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and th Terminated |
JQP | None listed |
| Nov 3, 2015 | bioMerieux, Inc. MYLA MASTER DVD V4.1 CLI
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) ( Terminated |
JQP | None listed |
| Nov 3, 2015 | bioMerieux, Inc. MYLA MASTER DVD V4.0 CLI
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) ( Terminated |
JQP | None listed |
| Nov 3, 2015 | bioMerieux, Inc. MYLA CLINIC PATCH 3.3.0 CD
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) Terminated |
JQP | None listed |
| Nov 3, 2015 | bioMerieux, Inc. MYLA MASTER DVD 3.2 CLI DL380
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS Terminated |
JQP | None listed |
| Nov 3, 2015 | bioMerieux, Inc. MYLA CLINIC PATCH 3.2.0 CD
Product Usage:
MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) Terminated |
JQP | None listed |
| Aug 26, 2015 | Siemens Healthcare Diagnostics, Inc. syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjun Terminated |
JQP | None listed |
| Aug 24, 2015 | Perkin Elmer Life Sciences Inc Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. Terminated |
JQP | None listed |
| Jul 27, 2015 | McKesson Technologies, Inc. Paragon Laboratory Management Terminated |
JQP | None listed |
| Jul 2, 2015 | Siemens Healthcare Diagnostics, Inc. CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software c Terminated |
JQP | None listed |
| Jun 30, 2015 | Siemens Healthcare Diagnostics, Inc. EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, Terminated |
JQP | None listed |
| Apr 2, 2015 | Roche Diabetes Care, Inc. ACCU-CHEK Connect Diabetes Management App; Instruction Manual
Designed to transfer data for diabetes management. Terminated |
JQP | K141929 |
| Mar 5, 2015 | Merge Healthcare, Inc. Merge LIS software. Terminated |
JQP | None listed |
| Feb 9, 2015 | SCC Soft Computer SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0 Terminated |
JQP | None listed |
| Feb 2, 2015 | SCC Soft Computer SoftLab with SA HIS versions 4.0.7.0-4.0.7.1
SoftLab is a laboratory information system to be used in a medical research or clinical laboratory. Terminated |
JQP | None listed |
| Jan 15, 2015 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager fo Terminated |
JQP | None listed |
| Sep 12, 2014 | Data Innovations, LLC ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below
JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Labo Terminated |
JQP | None listed |
| Sep 6, 2014 | Radiometer America Inc RADIANCE v. 2.4X, 2.5X and 2.6X
Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also Terminated |
JQP | None listed |
| Sep 1, 2014 | Siemens Healthcare Diagnostics, Inc. Siemens EasyLink Informatics System V4.0/V5
Siemens, Material Number (SMN)
10444799, 10444800, 10487219
A clinical data management system that assists medical laboratory professionals with preanalyt Terminated |
JQP | None listed |
| Sep 1, 2014 | Roche Diagnostics Operations, Inc. Roche cobas IT 1000
Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data. Terminated |
JQP | None listed |
| Aug 7, 2014 | PerkinElmer Health Sciences, Inc. PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500
Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrie Terminated |
JQP | None listed |
| Jul 17, 2014 | Siemens Healthcare Diagnostics Inc Siemens RAPIDComm Data Management System.
The RAPIDComm Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital Terminated |
JQP | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.