Product code CEJ— Clinical Chemistry
POTASSIUM REAGENT SET
- Classification name
- Tetraphenyl Borate, Colorimetry, Potassium
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code CEJ
FDA has cleared devices under product code CEJ between 1981 and 2005, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2005
- 1994
- 1990
- 1988
- 1986
- 1985
- 1983
- 1982
- 1981
Top applicants under product code CEJ
Recent clearances under product code CEJ
- K043267 — POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
- K943026 — POTASSIUM QVET
- K904033 — REFLOTRON POTASSIUM TEST TABS
- K902574 — POTASSIUM REAGENT SET
- K883585 — TECHNICON ASSIST POTASSIUM
- K883586 — TECHNICON RA-100 SYSTEM POTASSIUM
- K881440 — IQ POTASSIUM
- K880339 — EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
- K863486 — POTASSIUM TEST
- K861713 — SERUM POTASSIUM REAGENT SET
- K853404 — QCA POTASSIUM TEST KIT
- K850258 — BCS POTASSIUM TURBIDIMETRIC TEST
- K832553 — POTASSIUM TEST KIT
- K813608 — POTASSIUM REAGENT SET
- K812677 — UNITEST-POTASSIUM
- K811661 — POTASSIUM TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.