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)
Top companies in JJE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2019 | Abbott 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 |
JJE | K980367 |
| Apr 15, 2019 | Abbott 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 |
JJE | None listed |
| Apr 8, 2019 | Ortho-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 |
JJE | K922072 |
| Apr 8, 2019 | Ortho-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 |
JJE | K922072 |
| Apr 8, 2019 | Ortho-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 |
JJE | K922072 |
| Apr 8, 2019 | Ortho-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 |
JJE | K922072 |
| Apr 5, 2019 | Abbott 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 |
JJE | None listed |
| Mar 30, 2019 | Beckman 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 |
JJE | K042291 |
| Mar 30, 2019 | Beckman 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 |
JJE | K023764 |
| Mar 20, 2019 | Ortho-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 |
JJE | K182063 |
| Mar 15, 2019 | Roche Diagnostics Corporation cobas e 801 immunoassay analyzer Terminated |
JJE | K100853 K162606 +1 |
| Mar 11, 2019 | Ortho-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 |
JJE | K182063 |
| Mar 7, 2019 | Abbott 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 |
JJE | None listed |
| Feb 26, 2019 | Abbott 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 |
JJE | None listed |
| Feb 26, 2019 | Abbott 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 |
JJE | None listed |
| Feb 20, 2019 | Ortho-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 |
JJE | K182063 |
| Feb 20, 2019 | Ortho-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 |
JJE | K083173 |
| Feb 20, 2019 | Ortho-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 |
JJE | K083173 |
| Feb 20, 2019 | Ortho-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 |
JJE | K081543 |
| Feb 20, 2019 | Ortho-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 |
JJE | K081543 |
| Feb 15, 2019 | Alere 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 |
JJE | K120615 |
| Jan 10, 2019 | Bio-Rad Laboratories, Inc EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A. Open, Classified |
JJE | None listed |
| Dec 20, 2018 | Abbott 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 |
JJE | None listed |
| Dec 14, 2018 | Roche 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 |
JJE | K024098 K873049 |
| Dec 14, 2018 | Roche 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 |
JJE | K013249 K101203 |
| Dec 12, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 1500, Analyzer, chemistry Model no. 10444801 Terminated |
JJE | K143720 |
| Dec 12, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 500, Analyzer, chemistry Model no. 10284473 Terminated |
JJE | K051087 |
| Oct 19, 2018 | Ortho-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 |
JJE | K063144 |
| Oct 19, 2018 | Ortho-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 |
JJE | K083173 |
| Oct 19, 2018 | Ortho-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 |
JJE | K063144 |
| Oct 19, 2018 | Ortho-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 |
JJE | K081543 |
| Oct 16, 2018 | Siemens 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 |
JJE | K143720 |
| Oct 16, 2018 | Siemens 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 |
JJE | K051087 |
| Sep 28, 2018 | Siemens 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 |
JJE | K112999 K130276 |
| Jul 17, 2018 | Abbott 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 |
JJE | K980367 |
| Jul 17, 2018 | Abbott 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 |
JJE | K980367 |
| Jul 17, 2018 | Abbott 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 |
JJE | K980367 |
| Jun 29, 2018 | Siemens 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 |
JJE | K151767 |
| Jun 29, 2018 | Siemens 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 |
JJE | K151792 |
| Jun 29, 2018 | Siemens 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 |
JJE | K151792 |
| Jun 29, 2018 | Siemens 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 |
JJE | K161954 |
| Jun 29, 2018 | Siemens 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 |
JJE | K161954 |
| Jun 29, 2018 | Siemens 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 |
JJE | K161954 |
| May 25, 2018 | Radiometer 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 |
JJE | K120197 |
| May 9, 2018 | bioMerieux, 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 |
JJE | K923579 |
| May 9, 2018 | bioMerieux, 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 |
JJE | K923579 |
| May 4, 2018 | Randox Laboratories RX Imola (RX4900)
For Professional Use for the quantitative in vitro determination of various clinical chemistry tests. Terminated |
JJE | K052914 |
| Apr 3, 2018 | Roche 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 |
JJE | K100853 K162606 +1 |
| Apr 2, 2018 | Bio-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 |
JJE | None listed |
| Mar 1, 2018 | bioMerieux, 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 |
JJE | None listed |
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