DeviceClearance

Product code CIJ— Clinical Chemistry

-AMYLASE EPS

Classification name
Saccharogenic, Amylase
Device class
Class 2
Regulation
21 CFR 862.1070
Advisory panel
Clinical Chemistry
Total cleared
31
First cleared
Most recent

Market context for product code CIJ

FDA has cleared 31 devices under product code CIJ between 1976 and 2002, filed by 22 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 CIJ

Recent clearances under product code CIJ

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