Panels › Clinical Chemistry › Product code CEM · Class 2
Electrode, Ion Specific, Potassium
Regulation 862.1600
1510(k)s in 12 months (89 all time)
3recalls in 12 months (63 all time)
61recalls that name a 510(k)
Top companies in CEM
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 1987 | K870657 | AVL MODEL 985 ELECTROLYTE ANALYZER Avl Scientific Corp. | CEM |
| Jan 21, 1987 | K870033 | AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460 American Research Products Co. | CEM |
| Mar 5, 1986 | K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) Smithkline Diagnostics, Inc. | CEM |
| Nov 12, 1985 | K854298 | IRON Boehringer Mannheim Corp. | CEM |
| Oct 31, 1985 | K853068 | ILEX PROMPT CLINICAL CHEMISTRY ANALYER Ilex Corp. | CEM |
| Sep 4, 1985 | K853531 | ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER American Dade | CEM |
| Sep 3, 1985 | K853356 | SERA-210 ELECTROLYTE ANALYZER Horiba Instruments, Inc. | CEM |
| Aug 12, 1985 | K850950 | VISION POTASSIUM Abbott Laboratories | CEM |
| Jul 9, 1985 | K851100 | CHEM PRO 1000 CHEMISTRY ANALYSIS Sen Tech Medical Corp. | CEM |
| Jun 25, 1985 | K851808 | ELECTROLYTE ANALYZER Ionetics, Inc. | CEM |
| Apr 29, 1985 | K851350 | ION 2 REAGENT KI Hi Chem, Inc. | CEM |
| Mar 19, 1985 | K844955 | SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & Miles Laboratories, Inc. | CEM |
| Jan 8, 1985 | K844806 | MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 Horiba Instruments, Inc. | CEM |
| Nov 27, 1984 | K844044 | LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER Medica Corp. | CEM |
| Nov 27, 1984 | K843454 | ULTRA LYTE POTASSIUM REAGENT KIT Ultra Quest Diagnostics, Inc. | CEM |
| Oct 17, 1984 | K843239 | DACOS PLUS LYTES OPTION Coulter Electronics, Inc. | CEM |
| Sep 14, 1984 | K842786 | DYNA-LYTE 2000 Abbott Diagnostics | CEM |
| Sep 4, 1984 | K843008 | ION SELECTIVE ELECTRODES & REAGENT SYS American Monitor Corp. | CEM |
| Aug 10, 1984 | K840961 | ESCHWEILER COMBI-ANALYSER MTA-500 U.S. Science, Inc. | CEM |
| Aug 2, 1984 | K842315 | ULTRA LYTE ANALYZER I 100 Ultra Quest Diagnostics, Inc. | CEM |
| Jul 6, 1984 | K841575 | SENTECH'S ULAB 1000 CLINICAL CHEM. Sen Tech Medical Corp. | CEM |
| Apr 18, 1984 | K840887 | AMRESCO E2A REAGENT SET 0562 & 0626 American Research Products Co. | CEM |
| Jan 18, 1984 | K833696 | ACID BASE LABORATORY ABL4 Radiometer America, Inc. | CEM |
| Dec 29, 1983 | K833776 | QEA SODIUM/POTASSIUM ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic | CEM |
| Nov 25, 1983 | K833159 | POTASSIUM ELECTRODE TIP ASSAMBLY-K- Hi Chem, Inc. | CEM |
| Jul 18, 1983 | K832036 | QEA SODIUM/POTASSIUM ANALYZER Bd Becton Dickinson Vacutainer Systems Preanalytic | CEM |
| Jan 28, 1983 | K830104 | SERUM IRON DIAGNOSTIC TEST KITS Sclavo, Inc. | CEM |
| Oct 8, 1982 | K822441 | UNIMETER 330K Boehringer Mannheim Corp. | CEM |
| Jul 2, 1982 | K821822 | MODEL 1020 NA/K ANALYZER Thermo Orion | CEM |
| Jul 10, 1981 | K811310 | SODIUM/POTASSIUM REAGENT KITS Chem-Elec, Inc. | CEM |
| Oct 10, 1980 | K802158 | POSTASSIUM BUFFER SOL. & WASH SOLUTION Panmed, Inc. | CEM |
| May 28, 1980 | K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN Diagnostic Solutions, Inc. | CEM |
| Feb 5, 1980 | K800054 | KODAK EKTACHEM ELECTROLYTE ANALYZER Eastman Kodak Company | CEM |
| Jan 21, 1980 | K800016 | DUPONT ACA ION SELECTIVE ELECTRODE E.I. Dupont DE Nemours & Co., Inc. | CEM |
| Sep 17, 1979 | K791692 | SODIUM/POTASSIUM BUFFER SOLUTION Hi Chem, Inc. | CEM |
| Aug 10, 1979 | K791175 | ANALYZER, SODIUM/POTASSIUM Nova Biomedical Corp. | CEM |
| Feb 1, 1979 | K790018 | SERUM, POTASSIUM DETERMINATION OF Fisher Scientific Co., LLC | CEM |
| Nov 2, 1977 | K771837 | POTASSIUM Gamma Enterprises, Inc. | CEM |
| Jul 11, 1977 | K771118 | CENTRIA SEPARATION COLUMNS TYPE A Clinical Diagnostics, Inc. | CEM |
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