CEJ
16 FDA 510(k) clearances · Product code
30 daysmedian time to decision
98 days90th percentile
16clearances measured
FDA profile
- Official device name
- Tetraphenyl Borate, Colorimetry, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2003: 1 · 2010: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 (K043267) | Randox Laboratories, Ltd. | 2005-02-10 |
| POTASSIUM QVET (K943026) | Prisma Systems | 1994-12-09 |
| REFLOTRON POTASSIUM TEST TABS (K904033) | Boehringer Mannheim Corp. | 1990-11-06 |
| POTASSIUM REAGENT SET (K902574) | Tech-Co, Inc. | 1990-07-10 |
| TECHNICON RA-100 SYSTEM POTASSIUM (K883586) | Technicon Instruments Corp. | 1988-11-29 |
| TECHNICON ASSIST POTASSIUM (K883585) | Technicon Instruments Corp. | 1988-11-29 |
| IQ POTASSIUM (K881440) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-05-27 |
| EASY-TEST POTASSIUM K ITEM NUMBER 19XXX (K880339) | Em Diagnostic Systems, Inc. | 1988-02-25 |
| POTASSIUM TEST (K863486) | Sclavo, Inc. | 1986-09-29 |
| SERUM POTASSIUM REAGENT SET (K861713) | Sterling Diagnostics, Inc. | 1986-05-23 |
| QCA POTASSIUM TEST KIT (K853404) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-08-23 |
| BCS POTASSIUM TURBIDIMETRIC TEST (K850258) | Bioclinical Systems, Inc. | 1985-02-07 |
| POTASSIUM TEST KIT (K832553) | Mallinckrodt Critical Care | 1983-09-20 |
| POTASSIUM REAGENT SET (K813608) | Diagnostic Specialties | 1982-01-22 |
| UNITEST-POTASSIUM (K812677) | Biodynamics Corp. | 1981-10-02 |
| POTASSIUM TEST (K811661) | King Diagnostics, Inc. | 1981-06-25 |
Track CEJ automatically
Every clearance here is in the API, with alerts when new ones post.