CEJ — Tetraphenyl Borate, Colorimetry, Potassium Class II
FDA Device Classification
Classification Details
- Product Code
- CEJ
- Device Class
- Class II
- Regulation Number
- 862.1600
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K043267 | randox laboratories | POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 | February 10, 2005 |
| K943026 | prisma systems | POTASSIUM QVET | December 9, 1994 |
| K904033 | boehringer mannheim | REFLOTRON POTASSIUM TEST TABS | November 6, 1990 |
| K902574 | tech-co | POTASSIUM REAGENT SET | July 10, 1990 |
| K883585 | technicon instruments | TECHNICON ASSIST POTASSIUM | November 29, 1988 |
| K883586 | technicon instruments | TECHNICON RA-100 SYSTEM POTASSIUM | November 29, 1988 |
| K881440 | bd becton dickinson vacutainer systems preanalytic | IQ POTASSIUM | May 27, 1988 |
| K880339 | em diagnostic systems | EASY-TEST POTASSIUM K ITEM NUMBER 19XXX | February 25, 1988 |
| K863486 | sclavo | POTASSIUM TEST | September 29, 1986 |
| K861713 | sterling diagnostics | SERUM POTASSIUM REAGENT SET | May 23, 1986 |
| K853404 | bd becton dickinson vacutainer systems preanalytic | QCA POTASSIUM TEST KIT | August 23, 1985 |
| K850258 | bioclinical systems | BCS POTASSIUM TURBIDIMETRIC TEST | February 7, 1985 |
| K832553 | mallinckrodt critical care | POTASSIUM TEST KIT | September 20, 1983 |
| K813608 | diagnostic specialties | POTASSIUM REAGENT SET | January 22, 1982 |
| K812677 | biodynamics | UNITEST-POTASSIUM | October 2, 1981 |
| K811661 | king diagnostics | POTASSIUM TEST | June 25, 1981 |