Tetraphenyl Borate, Colorimetry, Potassium
FDA product code CEJ · Class II (moderate risk) · 21 CFR 862.1600 · Clinical Chemistry
16510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Technicon Instruments Corp. 2
- King Diagnostics, Inc. 1
- Biodynamics Corp. 1
- Diagnostic Specialties 1
- Mallinckrodt Critical Care 1
- Bioclinical Systems, Inc. 1
- Sterling Diagnostics, Inc. 1
- Sclavo, Inc. 1
- Em Diagnostic Systems, Inc. 1
- Tech-Co, Inc. 1
- Boehringer Mannheim Corp. 1
- Prisma Systems 1
- Randox Laboratories, Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043267 | Potassium Test Kit and Electrolyte Cal 1 and 2CEJ · Traditional | Randox Laboratories, Ltd. | 02/10/2005SE |
| K943026 | Potassium QvetCEJ · Traditional | Prisma Systems | 12/09/1994SE |
| K904033 | Reflotron Potassium Test TabsCEJ · Traditional | Boehringer Mannheim Corp. | 11/06/1990SE |
| K902574 | Potassium Reagent SetCEJ · Traditional | Tech-Co, Inc. | 07/10/1990SE |
| K883586 | Technicon RA-100 System PotassiumCEJ · Traditional | Technicon Instruments Corp. | 11/29/1988SE |
| K883585 | Technicon Assist PotassiumCEJ · Traditional | Technicon Instruments Corp. | 11/29/1988SE |
| K881440 | Iq PotassiumCEJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/27/1988SE |
| K880339 | Easy-Test Potassium K Item Number 19XXXCEJ · Traditional | Em Diagnostic Systems, Inc. | 02/25/1988SE |
| K863486 | Potassium TestCEJ · Traditional | Sclavo, Inc. | 09/29/1986SE |
| K861713 | Serum Potassium Reagent SetCEJ · Traditional | Sterling Diagnostics, Inc. | 05/23/1986SE |
| K853404 | Qca Potassium Test KitCEJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/23/1985SE |
| K850258 | BCS Potassium Turbidimetric TestCEJ · Traditional | Bioclinical Systems, Inc. | 02/07/1985SE |
| K832553 | Potassium Test KitCEJ · Traditional | Mallinckrodt Critical Care | 09/20/1983SE |
| K813608 | Potassium Reagent SetCEJ · Traditional | Diagnostic Specialties | 01/22/1982SE |
| K812677 | Unitest-PotassiumCEJ · Traditional | Biodynamics Corp. | 10/02/1981SE |
| K811661 | Potassium TestCEJ · Traditional | King Diagnostics, Inc. | 06/25/1981SE |