FDA Product Code
FDA Product Code CEJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1600
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K043267 | POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 | Randox Laboratories, Ltd. | 2005-02-10 | Traditional | PDF ↗ |
| K943026 | POTASSIUM QVET | Prisma Systems | 1994-12-09 | Traditional | PDF ↗ |
| K904033 | REFLOTRON POTASSIUM TEST TABS | Boehringer Mannheim Corp. | 1990-11-06 | Traditional | PDF ↗ |
| K902574 | POTASSIUM REAGENT SET | Tech-Co, Inc. | 1990-07-10 | Traditional | PDF ↗ |
| K883586 | TECHNICON RA-100 SYSTEM POTASSIUM | Technicon Instruments Corp. | 1988-11-29 | Traditional | PDF ↗ |
| K883585 | TECHNICON ASSIST POTASSIUM | Technicon Instruments Corp. | 1988-11-29 | Traditional | PDF ↗ |
| K881440 | IQ POTASSIUM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-05-27 | Traditional | PDF ↗ |
| K880339 | EASY-TEST POTASSIUM K ITEM NUMBER 19XXX | Em Diagnostic Systems, Inc. | 1988-02-25 | Traditional | PDF ↗ |
| K863486 | POTASSIUM TEST | Sclavo, Inc. | 1986-09-29 | Traditional | PDF ↗ |
| K861713 | SERUM POTASSIUM REAGENT SET | Sterling Diagnostics, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K853404 | QCA POTASSIUM TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-08-23 | Traditional | PDF ↗ |
| K850258 | BCS POTASSIUM TURBIDIMETRIC TEST | Bioclinical Systems, Inc. | 1985-02-07 | Traditional | PDF ↗ |
| K832553 | POTASSIUM TEST KIT | Mallinckrodt Critical Care | 1983-09-20 | Traditional | PDF ↗ |
| K813608 | POTASSIUM REAGENT SET | Diagnostic Specialties | 1982-01-22 | Traditional | PDF ↗ |
| K812677 | UNITEST-POTASSIUM | Biodynamics Corp. | 1981-10-02 | Traditional | PDF ↗ |
| K811661 | POTASSIUM TEST | King Diagnostics, Inc. | 1981-06-25 | Traditional | PDF ↗ |
Product code CEJ · Class II · Clinical Chemistry. Data: openFDA.