ClearanceBrief
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)
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Top companies in JQP

DateFirm and productCodeLinked 510(k)
Jan 18, 2018Beckman Coulter Inc.
AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
Terminated
JQPNone listed
Nov 17, 2017PerkinElmer 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
JQPNone listed
Oct 16, 2017Normand 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
JQPNone listed
Sep 12, 2017Abbott 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
JQPNone listed
May 25, 2017Merge 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
JQPNone listed
May 9, 2017Roche 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
JQPNone listed
Mar 23, 2017Roche Diagnostics Corporation
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
Terminated
JQPNone listed
Mar 23, 2017Roche Diagnostics Corporation
Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
Terminated
JQPNone listed
Mar 13, 2017PerkinElmer 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
JQPNone listed
Feb 27, 2017Becton 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
JQPNone listed
Feb 16, 2017Data 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
JQPNone listed
Jan 24, 2017Roche Diagnostics Corporation
cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
Terminated
JQPNone listed
Jan 18, 2017Beckman 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
JQPNone listed
Dec 23, 2016PerkinElmer 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
JQPNone listed
Nov 29, 2016Siemens 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Jul 15, 2016Roche 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
JQPNone listed
Feb 23, 2016Roche 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
JQPNone listed
Nov 18, 2015Roche 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
JQPNone listed
Nov 3, 2015bioMerieux, 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
JQPNone listed
Nov 3, 2015bioMerieux, 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
JQPNone listed
Nov 3, 2015bioMerieux, 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
JQPNone listed
Nov 3, 2015bioMerieux, 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
JQPNone listed
Nov 3, 2015bioMerieux, 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
JQPNone listed
Nov 3, 2015bioMerieux, 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
JQPNone listed
Nov 3, 2015bioMerieux, 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
JQPNone listed
Aug 26, 2015Siemens 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
JQPNone listed
Aug 24, 2015Perkin 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
JQPNone listed
Jul 27, 2015McKesson Technologies, Inc.
Paragon Laboratory Management
Terminated
JQPNone listed
Jul 2, 2015Siemens 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
JQPNone listed
Jun 30, 2015Siemens 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
JQPNone listed
Apr 2, 2015Roche Diabetes Care, Inc.
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Terminated
JQPK141929
Mar 5, 2015Merge Healthcare, Inc.
Merge LIS software.
Terminated
JQPNone listed
Feb 9, 2015SCC 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
JQPNone listed
Feb 2, 2015SCC 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
JQPNone listed
Jan 15, 2015Siemens 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
JQPNone listed
Sep 12, 2014Data 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
JQPNone listed
Sep 6, 2014Radiometer 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
JQPNone listed
Sep 1, 2014Siemens 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
JQPNone listed
Sep 1, 2014Roche Diagnostics Operations, Inc.
Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
Terminated
JQPNone listed
Aug 7, 2014PerkinElmer 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
JQPNone listed
Jul 17, 2014Siemens 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
JQPNone listed

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