JJE · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Clinical Chemistry · 21 CFR 862.2160 · Class 1
Overview
| Product Code | JJE |
|---|---|
| Device Name | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Regulation | 21 CFR 862.2160 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 208)
Showing 20 most recent of 208 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | Horiba, Ltd. | Feb 12, 2019 | SESE |
| K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | Carolina Liquid Chemistries Corp. | May 16, 2014 | SESE |
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | Jas Diagnostics, Inc. | May 15, 2014 | SESE |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | Randox Laboratories, Ltd. | Jan 9, 2014 | SESE |
| K130276 | DIMENSION EXL WITH LM SYSTEM | Siemens Healthcare Diagnostics, Inc. | Mar 22, 2013 | SESE |
| K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | May 17, 2012 | SESE |
| K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM | Siemens Healthcare Diagnostics | Nov 22, 2011 | SESE |
| K110035 | INDIKO | Thermofisher Scientific OY | Jun 28, 2011 | SESE |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | Teco Diagnostics | May 8, 2008 | SESE |
| K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM | Ortho-Clinical Diagnostics, Inc. | Nov 13, 2006 | SESE |
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM | Dade Behring, Inc. | Jul 11, 2005 | SESE |
| K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | Stanbio Laboratory | Mar 14, 2005 | SESE |
| K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | Tokyo Boeki Medical System , Ltd. | Feb 15, 2005 | SESE |
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 | Beckman Coulter, Inc. | Jan 28, 2003 | SESE |
| K010500 | AUTOMATED WORKCELL CONTROL SOFTWARE | Lab-Interlink, Inc. | Aug 1, 2001 | SESE |
| K003721 | MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | Dec 18, 2000 | SESE |
| K002982 | OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | Oct 25, 2000 | SESE |
| K983345 | BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY | Bayer Corp. | Dec 7, 1998 | SESE |
| K974779 | ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER | Abbott Laboratories | Feb 13, 1998 | SESE |
| K974651 | ABBOTT AXSYM SYSTEM | Abbott Laboratories | Feb 12, 1998 | SESE |
Top Applicants
- Eastman Kodak Company — 18 clearances
- Boehringer Mannheim Corp. — 16 clearances
- Abbott Laboratories — 13 clearances
- Beckman Instruments, Inc. — 9 clearances
- Ciba Corning Diagnostics Corp. — 7 clearances
