CEJ · Tetraphenyl Borate, Colorimetry, Potassium
Clinical Chemistry · 21 CFR 862.1600 · Class 2
Overview
| Product Code | CEJ |
|---|---|
| Device Name | Tetraphenyl Borate, Colorimetry, Potassium |
| Regulation | 21 CFR 862.1600 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Classification Rationale
Class II.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K043267 | POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 | Randox Laboratories, Ltd. | Feb 10, 2005 | SESE |
| K943026 | POTASSIUM QVET | Prisma Systems | Dec 9, 1994 | SESE |
| K904033 | REFLOTRON POTASSIUM TEST TABS | Boehringer Mannheim Corp. | Nov 6, 1990 | SESE |
| K902574 | POTASSIUM REAGENT SET | Tech-Co, Inc. | Jul 10, 1990 | SESE |
| K883586 | TECHNICON RA-100 SYSTEM POTASSIUM | Technicon Instruments Corp. | Nov 29, 1988 | SESE |
| K883585 | TECHNICON ASSIST POTASSIUM | Technicon Instruments Corp. | Nov 29, 1988 | SESE |
| K881440 | IQ POTASSIUM | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 27, 1988 | SESE |
| K880339 | EASY-TEST POTASSIUM K ITEM NUMBER 19XXX | Em Diagnostic Systems, Inc. | Feb 25, 1988 | SESE |
| K863486 | POTASSIUM TEST | Sclavo, Inc. | Sep 29, 1986 | SESE |
| K861713 | SERUM POTASSIUM REAGENT SET | Sterling Diagnostics, Inc. | May 23, 1986 | SESE |
| K853404 | QCA POTASSIUM TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 23, 1985 | SESE |
| K850258 | BCS POTASSIUM TURBIDIMETRIC TEST | Bioclinical Systems, Inc. | Feb 7, 1985 | SESE |
| K832553 | POTASSIUM TEST KIT | Mallinckrodt Critical Care | Sep 20, 1983 | SESE |
| K813608 | POTASSIUM REAGENT SET | Diagnostic Specialties | Jan 22, 1982 | SESE |
| K812677 | UNITEST-POTASSIUM | Biodynamics Corp. | Oct 2, 1981 | SESE |
| K811661 | POTASSIUM TEST | King Diagnostics, Inc. | Jun 25, 1981 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Technicon Instruments Corp. — 2 clearances
- Bioclinical Systems, Inc. — 1 clearance
- Biodynamics Corp. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
