DeviceClearance

Product code JFJ— Clinical Chemistry

AMYLASE

Classification name
Catalytic Methods, Amylase
Device class
Class 2
Regulation
21 CFR 862.1070
Advisory panel
Clinical Chemistry
Total cleared
99
First cleared
Most recent

Market context for product code JFJ

FDA has cleared 99 devices under product code JFJ between 1977 and 2022, filed by 62 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 JFJ

Recent clearances under product code JFJ

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