CEJ — Tetraphenyl Borate, Colorimetry, Potassium Class II
FDA product code CEJ covers "Tetraphenyl Borate, Colorimetry, Potassium", a Class II medical device regulated under 21 CFR 862.1600. Submissions are reviewed by the Clinical Chemistry panel. At least 16 recent 510(k) clearances have been granted under this product code.
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 |