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)
Jul 31, 2026Copan WASP
Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used
Open, Classified
JQPNone listed
Jul 31, 2026Beckman Coulter Biomedical GmbH
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
Open, Classified
JQPNone listed
Oct 23, 2025Becton Dickinson & Co.
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3
Open, Classified
JQPNone listed
Sep 16, 2025Medical Information Technology, Inc.
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
Open, Classified
JQPNone listed
Jun 25, 2025Beckman Coulter Inc.
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMI
Open, Classified
JQPNone listed
Dec 3, 2024Becton Dickinson & Co.
BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
Open, Classified
JQPNone listed
Dec 3, 2024Becton Dickinson & Co.
BD EpiCenter Data Management System, Multi User Software Version or Model: 440981 Catalog Number: 440981
Open, Classified
JQPNone listed
Dec 3, 2024Becton Dickinson & Co.
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
Open, Classified
JQPNone listed
Dec 3, 2024Becton Dickinson & Co.
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Open, Classified
JQPNone listed
Oct 8, 2024Becton Dickinson & Co.
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality ac
Open, Classified
JQPNone listed
Jul 6, 2023Becton Dickinson & Co.
BD Synapsys Informatics Solution, Catalog Number 444150
Open, Classified
JQPNone listed
May 10, 2023Technidata S.A.
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
Open, Classified
JQPNone listed
Jan 12, 2023Roche Diagnostics Operations, Inc.
cobas infinity central lab, Material Number 07154003001
Open, Classified
JQPNone listed
Mar 9, 2022Roche Diabetes Care, Inc.
RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.
Terminated
JQPNone listed
Mar 9, 2022Becton Dickinson & Co.
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Terminated
JQPNone listed
Jul 15, 2021Beckman Coulter Inc.
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Terminated
JQPNone listed
Jun 24, 2021Roche Diagnostics Operations, Inc.
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Terminated
JQPNone listed
Jun 23, 2021Beckman Coulter, Inc.
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C Single User 1-year License C10576 - Kaluza C 10 User Network Licens
Terminated
JQPNone listed
Mar 31, 2021Soft Computer Consultants, Inc.
SoftCytogenetics
Terminated
JQPNone listed
Mar 31, 2021Soft Computer Consultants, Inc.
SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory sett
Terminated
JQPNone listed
Mar 22, 2021Normand-Info S.A.S.U.
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Terminated
JQPNone listed
Dec 17, 2020Roche Diagnostics Operations, Inc.
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
Terminated
JQPNone listed
Oct 9, 2020Roche Diagnostics Operations, Inc.
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software
Terminated
JQPNone listed
Apr 30, 2020Normand-Info S.A.S.U.
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &
Terminated
JQPNone listed
Apr 7, 2020Inpeco S.A.
Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX
Terminated
JQPK121012
Apr 7, 2020Inpeco S.A.
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - P
Terminated
JQPK121012
Apr 7, 2020Inpeco S.A.
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX
Terminated
JQPK121012
Apr 7, 2020Inpeco S.A.
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is
Terminated
JQPK121012
Jan 7, 2020Roche Diagnostics Operations, Inc.
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Terminated
JQPNone listed
Oct 8, 2019Roche Diagnostics Operations, Inc.
Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
Terminated
JQPNone listed
Aug 15, 2019Normand-Info S.A.S.U.
Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Terminated
JQPNone listed
Jul 3, 2019Roche Diagnostics Corporation
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Terminated
JQPNone listed
Jul 3, 2019Roche Diagnostics Corporation
cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
Terminated
JQPNone listed
Feb 21, 2019Becton Dickinson & Co.
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical di
Terminated
JQPNone listed
Feb 4, 2019Roche Diagnostics Corporation
Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Terminated
JQPNone listed
Nov 9, 2018Beckman Coulter Inc.
AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255
Open, Classified
JQPNone listed
Sep 17, 2018Beckman Coulter Inc.
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C
Terminated
JQPNone listed
Sep 7, 2018Abbott Laboratories, Inc
APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Terminated
JQPK093318
Aug 29, 2018Data Innovations, LLC
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
Terminated
JQPNone listed
Aug 24, 2018Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analyt
Terminated
JQPK121012
Jul 16, 2018Roche Diagnostics Corporation
Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and cen
Terminated
JQPNone listed
May 24, 2018Beckman Coulter Inc.
Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the
Terminated
JQPNone listed
May 24, 2018Beckman Coulter Inc.
Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which
Terminated
JQPNone listed
May 24, 2018Beckman Coulter Inc.
Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95343, Manufactured by: Beckman Coulter Biomedical GmbH Sorting-Drive software version 4.2 (released in October 2015) in
Terminated
JQPNone listed
May 24, 2018Beckman Coulter Inc.
Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). This
Terminated
JQPNone listed
May 24, 2018Beckman Coulter Inc.
Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be
Terminated
JQPNone listed
May 24, 2018Beckman Coulter Inc.
Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Fam
Terminated
JQPNone listed
May 24, 2018Beckman Coulter Inc.
Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for
Terminated
JQPNone listed
Feb 13, 2018Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Terminated
JQPK121012
Jan 19, 2018Beckman Coulter Inc.
AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125; AutoMate 2500 Catalog Number ODL25250; AutoMate 2550 Catalog Number ODL25255
Completed
JQPNone listed

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