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) |
|---|---|---|---|
| Jul 31, 2026 | Copan 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 |
JQP | None listed |
| Jul 31, 2026 | Beckman 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 |
JQP | None listed |
| Oct 23, 2025 | Becton 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 |
JQP | None listed |
| Sep 16, 2025 | Medical Information Technology, Inc. MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use. Open, Classified |
JQP | None listed |
| Jun 25, 2025 | Beckman 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 |
JQP | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD Synapsys Informatics Solution (Laboratory Solution)
Version or Model: 444150
Catalog Number: 444150 Open, Classified |
JQP | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD EpiCenter Data Management System, Multi User Software
Version or Model: 440981
Catalog Number: 440981 Open, Classified |
JQP | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD EpiCenter Data Management System
Version or Model: 440887
Catalog Number: 440887 Open, Classified |
JQP | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD EpiCenter Single User Software
Version or Model: 441007
Catalog Number: 441007 Open, Classified |
JQP | None listed |
| Oct 8, 2024 | Becton 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 |
JQP | None listed |
| Jul 6, 2023 | Becton Dickinson & Co. BD Synapsys Informatics Solution, Catalog Number 444150 Open, Classified |
JQP | None listed |
| May 10, 2023 | Technidata 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 |
JQP | None listed |
| Jan 12, 2023 | Roche Diagnostics Operations, Inc. cobas infinity central lab, Material Number 07154003001 Open, Classified |
JQP | None listed |
| Mar 9, 2022 | Roche 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 |
JQP | None listed |
| Mar 9, 2022 | Becton Dickinson & Co. BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10 Terminated |
JQP | None listed |
| Jul 15, 2021 | Beckman 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 |
JQP | None listed |
| Jun 24, 2021 | Roche Diagnostics Operations, Inc. cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 Terminated |
JQP | None listed |
| Jun 23, 2021 | Beckman 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 |
JQP | None listed |
| Mar 31, 2021 | Soft Computer Consultants, Inc. SoftCytogenetics Terminated |
JQP | None listed |
| Mar 31, 2021 | Soft 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 |
JQP | None listed |
| Mar 22, 2021 | Normand-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 |
JQP | None listed |
| Dec 17, 2020 | Roche 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 |
JQP | None listed |
| Oct 9, 2020 | Roche 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 |
JQP | None listed |
| Apr 30, 2020 | Normand-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 |
JQP | None listed |
| Apr 7, 2020 | Inpeco 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 |
JQP | K121012 |
| Apr 7, 2020 | Inpeco 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 |
JQP | K121012 |
| Apr 7, 2020 | Inpeco 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 |
JQP | K121012 |
| Apr 7, 2020 | Inpeco 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 |
JQP | K121012 |
| Jan 7, 2020 | Roche Diagnostics Operations, Inc. cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use. Terminated |
JQP | None listed |
| Oct 8, 2019 | Roche Diagnostics Operations, Inc. Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use
Material Number: 07154003001 Terminated |
JQP | None listed |
| Aug 15, 2019 | Normand-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 |
JQP | None listed |
| Jul 3, 2019 | Roche Diagnostics Corporation cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval. Terminated |
JQP | None listed |
| Jul 3, 2019 | Roche Diagnostics Corporation cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval. Terminated |
JQP | None listed |
| Feb 21, 2019 | Becton 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 |
JQP | None listed |
| Feb 4, 2019 | Roche Diagnostics Corporation Cobas infinity central lab IT solution
Material Number: 07154003001
Calculator/Data Processing Module, For Clinical Use Terminated |
JQP | None listed |
| Nov 9, 2018 | Beckman 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 |
JQP | None listed |
| Sep 17, 2018 | Beckman 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 |
JQP | None listed |
| Sep 7, 2018 | Abbott Laboratories, Inc APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product, Terminated |
JQP | K093318 |
| Aug 29, 2018 | Data 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 |
JQP | None listed |
| Aug 24, 2018 | Inpeco 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 |
JQP | K121012 |
| Jul 16, 2018 | Roche 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 |
JQP | None listed |
| May 24, 2018 | Beckman 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 |
JQP | None listed |
| May 24, 2018 | Beckman 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 |
JQP | None listed |
| May 24, 2018 | Beckman 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 |
JQP | None listed |
| May 24, 2018 | Beckman 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 |
JQP | None listed |
| May 24, 2018 | Beckman 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 |
JQP | None listed |
| May 24, 2018 | Beckman 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 |
JQP | None listed |
| May 24, 2018 | Beckman 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 |
JQP | None listed |
| Feb 13, 2018 | Inpeco S.A. FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System Terminated |
JQP | K121012 |
| Jan 19, 2018 | Beckman Coulter Inc. AutoMate 1200 Catalog Number ODL25120;
AutoMate 1250 Catalog Number ODL25125;
AutoMate 2500 Catalog Number ODL25250;
AutoMate 2550 Catalog Number ODL25255 Completed |
JQP | None listed |
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