DeviceClearance

Product code CJE— Clinical Chemistry

ALKALINE PHOSPHATASE

Classification name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device class
Class 2
Regulation
21 CFR 862.1050
Advisory panel
Clinical Chemistry
Total cleared
124
First cleared
Most recent

Market context for product code CJE

FDA has cleared 124 devices under product code CJE between 1976 and 2025, filed by 88 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

last 15 years

Top applicants under product code CJE

Recent clearances under product code CJE

1–100 of 124

Data sourced from openFDA. This site is unofficial and independent of the FDA.