FDA Product Code
FDA Product Code CEM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1600
510(k) Clearances — 89 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Roche Diagnostics | 2026-02-12 | Traditional | PDF ↗ |
| K241037 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2025-01-14 | Traditional | PDF ↗ |
| K220396 | EasyStat 300 | Medica Corporation | 2023-09-26 | Traditional | PDF ↗ |
| K230890 | ISE Electrodes | Randox Laboratories, Ltd. | 2023-09-08 | Special | PDF ↗ |
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics, Inc. | 2020-10-01 | Traditional | PDF ↗ |
| K121012 | FLEXLAB 3.6, ACCELERATOR A3600 | Inpeco S.P.A. | 2012-08-31 | Traditional | PDF ↗ |
| K121040 | SMARTLYTE ELECTROLYTE ANALYZER | Diamond Diagnostics, Inc. | 2012-08-30 | Traditional | PDF ↗ |
| K112995 | GEM PREMIER 4000 | Instrumentation Laboratory CO | 2012-05-03 | Traditional | PDF ↗ |
| K110520 | BIOLIS 12I | Tokyo Boeki Medisys, Inc. | 2012-03-23 | Traditional | PDF ↗ |
| K112412 | AU5800(R) CHEMISTRY ANALYZER | Beckman Coulter, Inc. | 2011-12-23 | Traditional | PDF ↗ |
| K112408 | POLY-CHEM 90 ISE MODULE | Polymedco, Inc. | 2011-11-04 | Traditional | PDF ↗ |
| K112788 | EASTLYTE NA/K/CA/PH | Medica Corp. | 2011-10-20 | Special | PDF ↗ |
| K092686 | ABL90 FLEX SERIES | Radiometer Medical Aps | 2010-08-06 | Traditional | PDF ↗ |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | Epocal, Inc. | 2010-03-30 | Traditional | PDF ↗ |
| K093318 | ACCELERATOR APS | Abbott Laboratories | 2010-02-19 | Traditional | PDF ↗ |
| K083680 | VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 | Ortho-Clinical Diagnostics, Inc. | 2009-02-27 | Special | PDF ↗ |
| K073157 | VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | 2007-12-07 | Special | PDF ↗ |
| K061107 | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 | Thermo Electron OY | 2006-08-08 | Traditional | PDF ↗ |
| K061730 | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 | Osmetech, Inc. | 2006-08-04 | Special | PDF ↗ |
| K052914 | RX IMOLA | Randox Laboratories, Ltd. | 2006-03-31 | Traditional | PDF ↗ |
| K060373 | COBAS 6000 SERIES SYSTEM | Roche Diagnostics | 2006-03-13 | Special | PDF ↗ |
| K042291 | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS | Beckman Coulter, Inc. | 2004-11-12 | Traditional | PDF ↗ |
| K040750 | BIO-CHEM ANALYZER, MODEL 100 | Clinical Analysis Corporation, Inc. | 2004-10-28 | Traditional | PDF ↗ |
| K042270 | STAT K IN VITRO DIAGNOSTIC TEST SYSTEM | Stat Chem, Inc. | 2004-10-06 | Traditional | PDF ↗ |
| K032311 | ROCHE DIAGNOSTICS OMNI S ANALYZER | Roche Diagnostics Corp. | 2003-10-17 | Traditional | PDF ↗ |
| K013373 | OMNI C ANALYZER | Roche Diagnostics Corp. | 2001-11-02 | Special | PDF ↗ |
| K010061 | DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND | Dade Behring, Inc. | 2001-03-14 | Traditional | PDF ↗ |
| K993083 | ALCYON 300I (WITH ISE MODULE) ANALYZER | Abbott Laboratories | 1999-10-05 | Special | PDF ↗ |
| K974784 | AVL OPTI CRITICAL CARE ANALYZER | Avl Scientific Corp. | 1998-02-24 | Traditional | PDF ↗ |
| K970330 | DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE | Dade Intl., Inc. | 1997-04-14 | Traditional | PDF ↗ |
| K961326 | EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER | Medica Corp. | 1996-06-21 | Traditional | PDF ↗ |
| K961115 | EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K932044 | DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD | Dupont Medical Products | 1993-07-27 | Traditional | PDF ↗ |
| K922943 | NOVA NA/K/CL/LI MODULE | Nova Biomedical Corp. | 1992-10-13 | Traditional | PDF ↗ |
| K923038 | MILES POTASSIUM METHOD | Heraeus Kulzer, Inc. | 1992-08-24 | Traditional | PDF ↗ |
| K915345 | STAT K SYSTEM | Portable Diagnostic Services, Inc. | 1992-07-16 | Traditional | PDF ↗ |
| K915178 | NOVA 11 NA/K/LI ANALYZER | Nova Biomedical Corp. | 1992-01-27 | Traditional | PDF ↗ |
| K915177 | NOVA 5 NA/K/C1 ALALYZER | Nova Biomedical Corp. | 1992-01-27 | Traditional | PDF ↗ |
| K912649 | ISE/K+ | Boehringer Mannheim Corp. | 1991-07-15 | Traditional | PDF ↗ |
| K900788 | MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER | Datachem, Inc. | 1990-07-05 | Traditional | PDF ↗ |
| K901039 | IONOMETER EH | Fresenius USA, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K901041 | IONOMETER EH-HK AND ACCESSORIES | Fresenius USA, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K900300 | LYTENING 2Z LYTENING SYSTEM 31 | Baxter Healthcare Corp | 1990-03-01 | Traditional | PDF ↗ |
| K897110 | SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM | Medisense, Inc. | 1990-02-27 | Traditional | PDF ↗ |
| K896692 | AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER | Baxter Healthcare Corp | 1990-01-02 | Traditional | PDF ↗ |
| K895664 | TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD | Technicon Instruments Corp. | 1989-11-14 | Traditional | PDF ↗ |
| K890792 | POTASSIUM AND SODIUM ELECTROLYTE ANALYZER | Ionetics, Inc. | 1989-05-03 | Traditional | PDF ↗ |
| K884769 | MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY | Ciba Corning Diagnostics Corp. | 1989-01-17 | Traditional | PDF ↗ |
| K884566 | VISION LYTE (TM) POTASSIUM | Abbott Laboratories | 1988-12-02 | Traditional | PDF ↗ |
| K883240 | AVL MODEL 986 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1988-09-22 | Traditional | PDF ↗ |
| K870657 | AVL MODEL 985 ELECTROLYTE ANALYZER | Avl Scientific Corp. | 1987-05-12 | Traditional | PDF ↗ |
| K870033 | AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460 | American Research Products Co. | 1987-01-21 | Traditional | PDF ↗ |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | Smithkline Diagnostics, Inc. | 1986-03-05 | Traditional | PDF ↗ |
| K854298 | IRON | Boehringer Mannheim Corp. | 1985-11-12 | Traditional | PDF ↗ |
| K853068 | ILEX PROMPT CLINICAL CHEMISTRY ANALYER | Ilex Corp. | 1985-10-31 | Traditional | PDF ↗ |
| K853531 | ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER | American Dade | 1985-09-04 | Traditional | PDF ↗ |
| K853356 | SERA-210 ELECTROLYTE ANALYZER | Horiba Instruments, Inc. | 1985-09-03 | Traditional | PDF ↗ |
| K850950 | VISION POTASSIUM | Abbott Laboratories | 1985-08-12 | Traditional | PDF ↗ |
| K851100 | CHEM PRO 1000 CHEMISTRY ANALYSIS | Sen Tech Medical Corp. | 1985-07-09 | Traditional | PDF ↗ |
| K851808 | ELECTROLYTE ANALYZER | Ionetics, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K851350 | ION 2 REAGENT KI | Hi Chem, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K844955 | SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & | Miles Laboratories, Inc. | 1985-03-19 | Traditional | PDF ↗ |
| K844806 | MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 | Horiba Instruments, Inc. | 1985-01-08 | Traditional | PDF ↗ |
| K844044 | LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER | Medica Corp. | 1984-11-27 | Traditional | PDF ↗ |
| K843454 | ULTRA LYTE POTASSIUM REAGENT KIT | Ultra Quest Diagnostics, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K843239 | DACOS PLUS LYTES OPTION | Coulter Electronics, Inc. | 1984-10-17 | Traditional | PDF ↗ |
| K842786 | DYNA-LYTE 2000 | Abbott Diagnostics | 1984-09-14 | Traditional | PDF ↗ |
| K843008 | ION SELECTIVE ELECTRODES & REAGENT SYS | American Monitor Corp. | 1984-09-04 | Traditional | PDF ↗ |
| K840961 | ESCHWEILER COMBI-ANALYSER MTA-500 | U.S. Science, Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K842315 | ULTRA LYTE ANALYZER I 100 | Ultra Quest Diagnostics, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K841575 | SENTECH'S ULAB 1000 CLINICAL CHEM. | Sen Tech Medical Corp. | 1984-07-06 | Traditional | PDF ↗ |
| K840887 | AMRESCO E2A REAGENT SET 0562 & 0626 | American Research Products Co. | 1984-04-18 | Traditional | PDF ↗ |
| K833696 | ACID BASE LABORATORY ABL4 | Radiometer America, Inc. | 1984-01-18 | Traditional | PDF ↗ |
| K833776 | QEA SODIUM/POTASSIUM ANALYZER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-12-29 | Traditional | PDF ↗ |
| K833159 | POTASSIUM ELECTRODE TIP ASSAMBLY-K- | Hi Chem, Inc. | 1983-11-25 | Traditional | PDF ↗ |
| K832036 | QEA SODIUM/POTASSIUM ANALYZER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-07-18 | Traditional | PDF ↗ |
| K830104 | SERUM IRON DIAGNOSTIC TEST KITS | Sclavo, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K822441 | UNIMETER 330K | Boehringer Mannheim Corp. | 1982-10-08 | Traditional | PDF ↗ |
| K821822 | MODEL 1020 NA/K ANALYZER | Thermo Orion | 1982-07-02 | Traditional | PDF ↗ |
| K811310 | SODIUM/POTASSIUM REAGENT KITS | Chem-Elec, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K802158 | POSTASSIUM BUFFER SOL. & WASH SOLUTION | Panmed, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN | Diagnostic Solutions, Inc. | 1980-05-28 | Traditional | PDF ↗ |
| K800054 | KODAK EKTACHEM ELECTROLYTE ANALYZER | Eastman Kodak Company | 1980-02-05 | Traditional | PDF ↗ |
| K800016 | DUPONT ACA ION SELECTIVE ELECTRODE | E.I. Dupont DE Nemours & Co., Inc. | 1980-01-21 | Traditional | PDF ↗ |
| K791692 | SODIUM/POTASSIUM BUFFER SOLUTION | Hi Chem, Inc. | 1979-09-17 | Traditional | PDF ↗ |
| K791175 | ANALYZER, SODIUM/POTASSIUM | Nova Biomedical Corp. | 1979-08-10 | Traditional | PDF ↗ |
| K790018 | SERUM, POTASSIUM DETERMINATION OF | Fisher Scientific Co., LLC | 1979-02-01 | Traditional | PDF ↗ |
| K771837 | POTASSIUM | Gamma Enterprises, Inc. | 1977-11-02 | Traditional | PDF ↗ |
| K771118 | CENTRIA SEPARATION COLUMNS TYPE A | Clinical Diagnostics, Inc. | 1977-07-11 | Traditional | PDF ↗ |
Product code CEM · Class II · Clinical Chemistry. Data: openFDA.