Panels › Clinical Chemistry › Product code LXG · Class 1
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Regulation 862.2050
0510(k)s in 12 months (3 all time)
1recalls in 12 months (28 all time)
4recalls that name a 510(k)
Top companies in LXG
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics Inc. | 0 | 10 |
| Beckman Coulter Inc | 0 | 5 |
| Biomedical Polymers, Inc. | 0 | 2 |
| Dynex Technologies, Inc. | 0 | 2 |
| Roche Diagnostics Operations, Inc. | 0 | 2 |
| Sysmex America, Inc. | 0 | 2 |
| Biomerieux Inc | 0 | 1 |
| Biomet, Inc. | 1 | 0 |
| Cambridge Diagnostic Products, Inc. | 1 | 0 |
| Helena Laboratories, Corp. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2026 | Sysmex America, Inc. TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17 Open, Classified |
LXG | None listed |
| Aug 22, 2025 | Dynex Technologies, Inc. Dynex Agility Sample Tips;
Model Number: 67910;
The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system. Open, Classified |
LXG | None listed |
| Jun 16, 2023 | Helena Laboratories, Corp. Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics Open, Classified |
LXG | None listed |
| Jul 5, 2020 | Dynex Technologies, Inc. DYNEX Agility, Agility Analyzer, Model No. 67000 Open, Classified |
LXG | None listed |
| Mar 9, 2020 | Sysmex America, Inc. The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to t Terminated |
LXG | None listed |
| Sep 18, 2019 | Biomedical Polymers, Inc. Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples. Terminated |
LXG | None listed |
| Sep 18, 2019 | Biomedical Polymers, Inc. Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples. Terminated |
LXG | None listed |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. STREAMLAB - REFRIGERATED STORAGE MODULE 15000 Terminated |
LXG | K082638 |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. STREAMLAB - REFRIGERATED STORAGE MODULE 9000 Terminated |
LXG | K082638 |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. STREAMLAB CORE UNIT / LYNX WITH IOM Terminated |
LXG | K082638 |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. APTIO RACK OUTPUT MODULE Terminated |
LXG | None listed |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. APTIO 9000 REFRIGERATED STORAGE MODULE Terminated |
LXG | None listed |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. APTIO 15000 REFRIGERATED STORAGE MODULE Terminated |
LXG | None listed |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. APTIO CENTRIFUGE MODULE Terminated |
LXG | None listed |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. APTIO RACK INPUT MODULE Terminated |
LXG | None listed |
| Aug 14, 2018 | Siemens Healthcare Diagnostics, Inc. APTIO INPUT/OUTPUT MODULE Terminated |
LXG | None listed |
| Aug 25, 2016 | Tecan US, Inc. Hydroflex ELISA
The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain info Terminated |
LXG | None listed |
| May 11, 2016 | Siemens Healthcare Diagnostics Inc. Hettich Centrifuge Modules:
StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836)
Aptio Centrifuge Module (10703032 or 10713761)
FlexLab High Throughput Centrifuge Module (11171747)
FlexLab a Terminated |
LXG | None listed |
| Jun 19, 2014 | Siemens Medical Solutions Diagnostics VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual Terminated |
LXG | K970227 |
| Oct 9, 2012 | Biomerieux Inc PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC.
Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples. Terminated |
LXG | None listed |
| Aug 29, 2011 | Roche Diagnostics Operations, Inc. MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24)
Roche Diagnostics Operations, Inc.
An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from Terminated |
LXG | None listed |
| Aug 29, 2011 | Roche Diagnostics Operations, Inc. MagNA Pure LC 1.0 (software version 3.0.11).
Roche Diagnostics Operations, Inc.
An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different Terminated |
LXG | None listed |
| May 19, 2011 | Beckman Coulter Inc. AutoMate TM Sample Processing System, P/N A20745 Basic Assembly - Automate
The AutoMate system prepares sample tubes for diagnostic testing and for storage. The AutoMate system contains an automated t Terminated |
LXG | None listed |
| May 18, 2009 | Roche Diagnostics Corp. Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 and 03670325001. Robotic workstation for automated isolation of nucleic acids from different kinds of crude sam Terminated |
LXG | None listed |
| Oct 16, 2007 | Beckman Coulter Inc FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Terminated |
LXG | None listed |
| Aug 31, 2006 | Beckman Coulter Inc FP1000 Cell Preparation System Part Number 624922 Terminated |
LXG | None listed |
| Jul 26, 2006 | Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System Part Numbers 626553 (TN; FC500 with UPS), 6605627 (TN; 5 CLR, FC500 (100V)), 6605628 (TN; 5 CLR, FC500 (120V)) , 6605629 (TN; 5 CLR, FC500 (220V)), 6605630 (TN; Terminated |
LXG | None listed |
| Aug 13, 2005 | Beckman Coulter Inc Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556. Terminated |
LXG | None listed |
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