JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Class I
FDA product code JJE covers "Analyzer, Chemistry (Photometric, Discrete), For Clinical Use", a Class I medical device regulated under 21 CFR 862.2160. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JJE
- Device Class
- Class I
- Regulation Number
- 862.2160
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183375 | horiba | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, | February 12, 2019 |
| K133519 | carolina liquid chemistries | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMIS | May 16, 2014 |
| K130915 | jas diagnostics | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | May 15, 2014 |
| K131554 | randox laboratories | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE ( | January 9, 2014 |
| K130276 | siemens healthcare diagnostics | DIMENSION EXL WITH LM SYSTEM | March 22, 2013 |
| K113253 | alfa wassermann diagnostic technologies | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGEN | May 17, 2012 |
| K112999 | siemens healthcare diagnostics | DIMENSION CLINICAL CHEMISTRY SYSTEM | November 22, 2011 |
| K110035 | thermofisher scientific | INDIKO | June 28, 2011 |
| K073370 | teco diagnostics | TC MATRIX CLINICAL CHEMISTRY ANALYZER | May 8, 2008 |
| K063144 | ortho-clinical diagnostics | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM | November 13, 2006 |
| K051087 | dade behring | DIMENSION VISTA INTEGRATED SYSTEM | July 11, 2005 |
| K042169 | stanbio laboratory | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | March 14, 2005 |
| K040958 | tokyo boeki medical system | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | February 15, 2005 |
| K023764 | beckman coulter | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 | January 28, 2003 |
| K010500 | lab-interlink | AUTOMATED WORKCELL CONTROL SOFTWARE | August 1, 2001 |
| K003721 | olympus america | MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | December 18, 2000 |
| K002982 | olympus america | OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | October 25, 2000 |
| K983345 | bayer | BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY | December 7, 1998 |
| K974779 | abbott laboratories | ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER | February 13, 1998 |
| K974651 | abbott laboratories | ABBOTT AXSYM SYSTEM | February 12, 1998 |