Product code JJE
- Device name
- Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2160
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P910007S013 | ABBOTT IMX TOTAL PSA | Abbott Laboratories | 2005-06-13 |
| P910007S011 | ABBOTT AXSYM TOTAL PSA ASSAY | Abbott Laboratories | 2004-09-27 |
| P910007S012 | ABBOTT ARCHITECT TOTAL PSA | Abbott Laboratories | 2004-09-10 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | Horiba, Ltd. | 2019-02-12 |
| K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | Carolina Liquid Chemistries Corp. | 2014-05-16 |
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | Jas Diagnostics, Inc. | 2014-05-15 |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | Randox Laboratories, Ltd. | 2014-01-09 |
| K130276 | DIMENSION EXL WITH LM SYSTEM | Siemens Healthcare Diagnostics, Inc. | 2013-03-22 |
| K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-05-17 |
| K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM | Siemens Healthcare Diagnostics | 2011-11-22 |
| K110035 | INDIKO | Thermofisher Scientific OY | 2011-06-28 |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | Teco Diagnostics | 2008-05-08 |
| K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM | Ortho-Clinical Diagnostics, Inc. | 2006-11-13 |
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM | Dade Behring, Inc. | 2005-07-11 |
| K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | Stanbio Laboratory | 2005-03-14 |
| K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | Tokyo Boeki Medical System , Ltd. | 2005-02-15 |
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 | Beckman Coulter, Inc. | 2003-01-28 |
| K010500 | AUTOMATED WORKCELL CONTROL SOFTWARE | Lab-Interlink, Inc. | 2001-08-01 |
| K003721 | MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 2000-12-18 |
| K002982 | OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 2000-10-25 |
| K983345 | BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY | Bayer Corp. | 1998-12-07 |
| K974779 | ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER | Abbott Laboratories | 1998-02-13 |
| K974651 | ABBOTT AXSYM SYSTEM | Abbott Laboratories | 1998-02-12 |
| K971761 | PERSONALLAB AUTOMATED MICROPLATE ANALYZER | Biochem Immunosystems (U.S.), Inc. | 1997-07-22 |
| K970227 | IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER | Dpc Cirrus | 1997-04-08 |
| K965240 | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L | Beckman Instruments, Inc. | 1997-03-10 |
| K961142 | STRATEC LIA II ANALYZER | Nichols Institute Diagnostics | 1997-02-18 |
| K963539 | SIGMA DIAGNOSTICS WASH CONCENTRATE | Sigma Diagnostics, Inc. | 1996-12-16 |
| K962231 | COBAS CORE IMMUNOCHEMISTRY SYSTEM | Roche Diagnostic Systems, Inc. | 1996-08-30 |
| K962125 | TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1996-08-02 |
| K961274 | OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 1996-07-05 |
| K962235 | VITROS SPECIALTY DILUENT | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-06-26 |
| K961481 | ELECSYS 2010 ANALYZER | Boehringer Mannheim Corp. | 1996-06-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810053950203 | NOVEOS Coconut, Cocos nucifera | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00816879027372 | NOVEOS Coconut, Cocos nucifera | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00816879025149 | NOVEOS Egg Yolk, Gallus gallus | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00816879025057 | NOVEOS Oyster, Ostrea edulis | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00816879024760 | NOVEOS Pecan Nut, Carya illinoensis | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00816879024548 | NOVEOS Salmon, Salmo salar | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00816879023886 | NOVEOS Pistachio Nut, Pistacia vera | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00816879023824 | NOVEOS Tuna, Thunnus sp. | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00810053950418 | NOVEOS Oyster, Ostrea edulis | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00810053950364 | NOVEOS Pistachio Nut, Pistacia vera | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00810053950340 | NOVEOS Pecan Nut, Carya illinoensis | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00810053950265 | NOVEOS Egg Yolk, Gallus gallus | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00810053950227 | NOVEOS Salmon, Salmo salar | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00810053950210 | NOVEOS Tuna, Thunnus sp. | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00810053950128 | NOVEOS Brazil Nut, Bertholletia excelsa | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 00816879023794 | NOVEOS Brazil Nut, Bertholletia excelsa | HYCOR BIOMEDICAL LLC | 2026-05-29 |
| 07613336224397 | cobas ISE neo 1800 analytical unit | Roche Diagnostics GmbH | 2026-04-03 |
| 10673486013962 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 10673486013580 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 10673486013726 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 10673486013894 | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer | TECO DIAGNOSTICS | 2025-05-28 |
| 00380740196257 | GLP systems Track | ABBOTT LABORATORIES | 2023-08-30 |
| 08033622964544 | Envoy | BIOTECNICA INSTRUMENTS SPA | 2020-09-18 |
| 08426951293865 | GEM Premier ChemSTAT | INSTRUMENTATION LABORATORY COMPANY | 2019-06-28 |
| 10054749000163 | i-STAT | ABBOTT POINT OF CARE INC. | 2016-09-09 |
| 00380740000370 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740000400 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740001179 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740000363 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740000394 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |