DeviceClearance

Product code JFH— Clinical Chemistry

ABBOTT PAP-EIA

Classification name
Acid Phosphatase (Prostatic), Tartrate Inhibited
Device class
Class 2
Regulation
21 CFR 862.1020
Advisory panel
Clinical Chemistry
Total cleared
45
First cleared
Most recent

Market context for product code JFH

FDA has cleared 45 devices under product code JFH between 1979 and 2000, filed by 33 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 JFH

Recent clearances under product code JFH

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