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Panels › Clinical Chemistry › Product code JJE · Class 1

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Regulation 862.2160

0510(k)s in 12 months (208 all time)
10recalls in 12 months (564 all time)
494recalls that name a 510(k)
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Top companies in JJE

DateFirm and productCodeLinked 510(k)
May 1, 2019Abbott Laboratories, Inc
ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a c
Terminated
JJEK980367
Apr 15, 2019Abbott Gmbh & Co. KG
Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistr
Terminated
JJENone listed
Apr 8, 2019Ortho-Clinical Diagnostics
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include
Terminated
JJEK922072
Apr 8, 2019Ortho-Clinical Diagnostics
VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologi
Terminated
JJEK922072
Apr 8, 2019Ortho-Clinical Diagnostics
VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include
Terminated
JJEK922072
Apr 8, 2019Ortho-Clinical Diagnostics
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include
Terminated
JJEK922072
Apr 5, 2019Abbott Gmbh & Co. KG
Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing
Terminated
JJENone listed
Mar 30, 2019Beckman Coulter Inc.
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an au
Open, Classified
JJEK042291
Mar 30, 2019Beckman Coulter Inc.
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 9731
Open, Classified
JJEK023764
Mar 20, 2019Ortho-Clinical Diagnostics
VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use i
Terminated
JJEK182063
Mar 15, 2019Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer
Terminated
JJEK100853
K162606 +1
Mar 11, 2019Ortho-Clinical Diagnostics
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and
Terminated
JJEK182063
Mar 7, 2019Abbott Gmbh & Co. KG
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , a
Terminated
JJENone listed
Feb 26, 2019Abbott Gmbh & Co. KG
Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and a
Terminated
JJENone listed
Feb 26, 2019Abbott Gmbh & Co. KG
Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and
Terminated
JJENone listed
Feb 20, 2019Ortho-Clinical Diagnostics
VITROS XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clini
Terminated
JJEK182063
Feb 20, 2019Ortho-Clinical Diagnostics
VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes
Terminated
JJEK083173
Feb 20, 2019Ortho-Clinical Diagnostics
VITROS 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical
Terminated
JJEK083173
Feb 20, 2019Ortho-Clinical Diagnostics
VITROS 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analyte
Terminated
JJEK081543
Feb 20, 2019Ortho-Clinical Diagnostics
VITROS 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clini
Terminated
JJEK081543
Feb 15, 2019Alere San Diego, Inc.
Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and
Terminated
JJEK120615
Jan 10, 2019Bio-Rad Laboratories, Inc
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Open, Classified
JJENone listed
Dec 20, 2018Abbott Gmbh & Co. KG
Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay ana
Terminated
JJENone listed
Dec 14, 2018Roche Diagnostics Corporation
cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Ap
Terminated
JJEK024098
K873049
Dec 14, 2018Roche Diagnostics Corporation
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine p
Terminated
JJEK013249
K101203
Dec 12, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
Terminated
JJEK143720
Dec 12, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
Terminated
JJEK051087
Oct 19, 2018Ortho-Clinical Diagnostics
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the anal
Terminated
JJEK063144
Oct 19, 2018Ortho-Clinical Diagnostics
VITROS 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on t
Terminated
JJEK083173
Oct 19, 2018Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the anal
Terminated
JJEK063144
Oct 19, 2018Ortho-Clinical Diagnostics
VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS
Terminated
JJEK081543
Oct 16, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to dete
Terminated
JJEK143720
Oct 16, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to deter
Terminated
JJEK051087
Sep 28, 2018Siemens Healthcare Diagnostics, Inc.
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension EXL 200 00630414593579; Dimension EXL with LM 00630414593500; Dimension EXL with LM with STM 00630414
Terminated
JJEK112999
K130276
Jul 17, 2018Abbott Laboratories, Inc
Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are
Terminated
JJEK980367
Jul 17, 2018Abbott Laboratories, Inc
Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are
Terminated
JJEK980367
Jul 17, 2018Abbott Laboratories, Inc
Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are
Terminated
JJEK980367
Jun 29, 2018Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Terminated
JJEK151767
Jun 29, 2018Siemens Healthcare Diagnostics, Inc.
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Terminated
JJEK151792
Jun 29, 2018Siemens Healthcare Diagnostics, Inc.
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Terminated
JJEK151792
Jun 29, 2018Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Terminated
JJEK161954
Jun 29, 2018Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Terminated
JJEK161954
Jun 29, 2018Siemens Healthcare Diagnostics, Inc.
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
Terminated
JJEK161954
May 25, 2018Radiometer America Inc
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oxim
Terminated
JJEK120197
May 9, 2018bioMerieux, Inc.
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS system to detect abnormal operation
Terminated
JJEK923579
May 9, 2018bioMerieux, Inc.
BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS system to detect abnormal opera
Terminated
JJEK923579
May 4, 2018Randox Laboratories
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Terminated
JJEK052914
Apr 3, 2018Roche Diagnostics Corporation
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is par
Terminated
JJEK100853
K162606 +1
Apr 2, 2018Bio-Rad Laboratories Inc
PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid
Terminated
JJENone listed
Mar 1, 2018bioMerieux, Inc.
VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in
Terminated
JJENone listed

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