ClearanceBrief
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)
Get daily alerts for LXGSample briefCSV

Top companies in LXG

Company510(k)sRecalls
Siemens Healthcare Diagnostics Inc.010
Beckman Coulter Inc05
Biomedical Polymers, Inc.02
Dynex Technologies, Inc.02
Roche Diagnostics Operations, Inc.02
Sysmex America, Inc.02
Biomerieux Inc01
Biomet, Inc.10
Cambridge Diagnostic Products, Inc.10
Helena Laboratories, Corp.01
DateFirm and productCodeLinked 510(k)
Jan 21, 2026Sysmex 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
LXGNone listed
Aug 22, 2025Dynex 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
LXGNone listed
Jun 16, 2023Helena 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
LXGNone listed
Jul 5, 2020Dynex Technologies, Inc.
DYNEX Agility, Agility Analyzer, Model No. 67000
Open, Classified
LXGNone listed
Mar 9, 2020Sysmex 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
LXGNone listed
Sep 18, 2019Biomedical Polymers, Inc.
Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples.
Terminated
LXGNone listed
Sep 18, 2019Biomedical Polymers, Inc.
Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood samples.
Terminated
LXGNone listed
Aug 14, 2018Siemens Healthcare Diagnostics, Inc.
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
Terminated
LXGK082638
Aug 14, 2018Siemens Healthcare Diagnostics, Inc.
STREAMLAB - REFRIGERATED STORAGE MODULE 9000
Terminated
LXGK082638
Aug 14, 2018Siemens Healthcare Diagnostics, Inc.
STREAMLAB CORE UNIT / LYNX WITH IOM
Terminated
LXGK082638
Aug 14, 2018Siemens Healthcare Diagnostics, Inc.
APTIO RACK OUTPUT MODULE
Terminated
LXGNone listed
Aug 14, 2018Siemens Healthcare Diagnostics, Inc.
APTIO 9000 REFRIGERATED STORAGE MODULE
Terminated
LXGNone listed
Aug 14, 2018Siemens Healthcare Diagnostics, Inc.
APTIO 15000 REFRIGERATED STORAGE MODULE
Terminated
LXGNone listed
Aug 14, 2018Siemens Healthcare Diagnostics, Inc.
APTIO CENTRIFUGE MODULE
Terminated
LXGNone listed
Aug 14, 2018Siemens Healthcare Diagnostics, Inc.
APTIO RACK INPUT MODULE
Terminated
LXGNone listed
Aug 14, 2018Siemens Healthcare Diagnostics, Inc.
APTIO INPUT/OUTPUT MODULE
Terminated
LXGNone listed
Aug 25, 2016Tecan 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
LXGNone listed
May 11, 2016Siemens 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
LXGNone listed
Jun 19, 2014Siemens 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
LXGK970227
Oct 9, 2012Biomerieux 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
LXGNone listed
Aug 29, 2011Roche 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
LXGNone listed
Aug 29, 2011Roche 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
LXGNone listed
May 19, 2011Beckman 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
LXGNone listed
May 18, 2009Roche 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
LXGNone listed
Oct 16, 2007Beckman Coulter Inc
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Terminated
LXGNone listed
Aug 31, 2006Beckman Coulter Inc
FP1000 Cell Preparation System Part Number 624922
Terminated
LXGNone listed
Jul 26, 2006Beckman 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
LXGNone listed
Aug 13, 2005Beckman Coulter Inc
Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556.
Terminated
LXGNone listed

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