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) |
|---|---|---|---|
| Jul 3, 2024 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic Open, Classified |
JJE | K221225 |
| Jun 28, 2024 | Beckman Coulter, Inc. Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, o Open, Classified |
JJE | None listed |
| May 9, 2024 | Randox Laboratories Ltd. Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination
of parent drug molecule and metabolites of drugs in human urine
Catalog Number: EV4115 Open, Classified |
JJE | K220451 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT 7600 Integrated System, Catalog No. 6844461 Open, Classified |
JJE | K182063 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT 3400 Chemistry System, Catalog No. 6844458 Open, Classified |
JJE | K182063 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) Open, Classified |
JJE | K081543 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) Open, Classified |
JJE | K031924 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Open, Classified |
JJE | K083173 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT 7600 Integrated System, Catalog No. 6844461 Open, Classified |
JJE | K182063 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT 3400 Chemistry System, Catalog No. 6844458 Open, Classified |
JJE | K182063 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) Open, Classified |
JJE | K081543 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) Open, Classified |
JJE | K031924 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished) Open, Classified |
JJE | K083173 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS XT7600 Integrated System Open, Classified |
JJE | K182063 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System (New and Refurbished) Open, Classified |
JJE | K081543 |
| Mar 1, 2024 | Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System (New and Refurbished) Open, Classified |
JJE | K083173 |
| Feb 5, 2024 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior, Open, Classified |
JJE | K221225 |
| Jan 9, 2024 | Abbott Laboratories ARCHITECT c4000 Processing Module REF:
02P24-01
02P24-02
02P24-40
01R24-56
01R25-56
The Abbott ARCHITECT c4000 Processing Module is designed to perform automated
chemistry tests, utilizing photometr Open, Classified |
JJE | None listed |
| Jan 9, 2024 | Abbott Laboratories Alinity c Processing Module REF 03R67-01
The Alinity c Processing Module is a fully automated chemistry analyzer allowing random
and continuous access, as well as priority and automated retest proce Open, Classified |
JJE | None listed |
| Jan 9, 2024 | Abbott Laboratories Alinity i Processing Module REF 03R65-01
The Alinity i Processing Module is a fully automated immunoassay analyzer allowing
random and continuous access, as well as priority and automated retest pro Open, Classified |
JJE | None listed |
| Dec 22, 2023 | Abbott Laboratories Alinity ci-series System Control Module, REF: 03R70-01 Open, Classified |
JJE | None listed |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0 Open, Classified |
JJE | K182063 |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 Open, Classified |
JJE | K182063 |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0 Open, Classified |
JJE | K081543 |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0 Open, Classified |
JJE | K031924 |
| Dec 13, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0 Open, Classified |
JJE | K083173 |
| Oct 12, 2023 | Beckman Coulter, Inc. DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic Open, Classified |
JJE | K221225 |
| Oct 2, 2023 | Ortho-Clinical Diagnostics, Inc. Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic Open, Classified |
JJE | K031924 K081543 +2 |
| Jul 26, 2023 | Beckman Coulter, Inc. Ringed DxI Reaction Vessels (RVs) Open, Classified |
JJE | K023764 |
| Jul 14, 2023 | Beckman Coulter Biomedical GmbH Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Open, Classified |
JJE | K190298 |
| Jul 14, 2023 | Beckman Coulter Biomedical GmbH Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Open, Classified |
JJE | K190298 |
| Jul 5, 2023 | Siemens Healthcare Diagnostics, Inc. Aptio Automation Storage and Retrieval Module (SRM) Open, Classified |
JJE | K043546 |
| May 4, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistr Open, Classified |
JJE | K081543 |
| May 4, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products
Micr Open, Classified |
JJE | K081543 |
| May 4, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products
Open, Classified |
JJE | K182063 |
| Mar 15, 2023 | Beckman Coulter, Inc. Access Immunoassay Systems
(1) Access 2 Immunoassay Analyzer
(81600N);
(2) Access 2 Immunoassay Analyzer, Refurbished (386220);
(3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and
(4) Acces Open, Classified |
JJE | K060256 K121214 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL.
Ref: 1220001769 Open, Classified |
JJE | None listed |
| Jul 19, 2022 | Ortho-Clinical Diagnostics, Inc. VITROS XT 7600 Integrated System with Version 3.7.2 and below
Product Code: 6844461 Open, Classified |
JJE | K182063 |
| Jul 19, 2022 | Ortho-Clinical Diagnostics, Inc. VITROS XT 3400 Chemistry System with Version 3.7.2 and below
Product Code: 6844458 Open, Classified |
JJE | K182063 |
| Jul 14, 2022 | Roche Diagnostics Operations, Inc. cobas e801 Immunoassay Analyzer Open, Classified |
JJE | None listed |
| Oct 15, 2021 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal Terminated |
JJE | K051087 K143720 |
| Oct 15, 2021 | Siemens Healthcare Diagnostics, Inc. Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of anal Terminated |
JJE | K051087 K143720 |
| Sep 29, 2021 | Abbott Laboratories ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25;
ARCHITECT c8000 REF 01G06-11/1G06;
ARCHITECT c16000 REF 03L77-01/3L77; Open, Classified |
JJE | K983212 |
| Sep 29, 2021 | Abbott Laboratories ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87;
ARCHITECT i2000SR REF 03M74-02/3M74;
ARCHITECT i2000 REF 08C89-01/1G17 and 8C89 Open, Classified |
JJE | K983212 |
| Sep 28, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM 1600 Analyzer, SMN 11066000 Open, Classified |
JJE | K151792 |
| Sep 28, 2021 | Siemens Healthcare Diagnostics, Inc Atellica IM 1300 Analyzer, SMN 11066001 Open, Classified |
JJE | K151792 |
| Jul 26, 2021 | Abbott Laboratories Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01 Open, Classified |
JJE | None listed |
| Jul 21, 2021 | Beckman Coulter Inc. DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118 Terminated |
JJE | K190298 |
| Apr 26, 2021 | Roche Diagnostics Operations, Inc. IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi Open, Classified |
JJE | K951595 |
| Jan 7, 2021 | Ortho-Clinical Diagnostics, Inc. VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory. Terminated |
JJE | None listed |
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