Product code JFN— Clinical Chemistry

CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY

Classification name
Atomic Absorption, Calcium
Device class
Class 2
Regulation
21 CFR 862.1145
Advisory panel
Clinical Chemistry
Total cleared
3
First cleared
Most recent

Market context for product code JFN

FDA has cleared 3 devices under product code JFN between 1977 and 1991, filed by 2 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

Top applicants under product code JFN

Recent clearances under product code JFN

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