DeviceClearance

Product code JGF— Clinical Chemistry

ABBOTT A-GENT LD-1 ISOZYME REAGENT

Classification name
Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Device class
Class 2
Regulation
21 CFR 862.1445
Advisory panel
Clinical Chemistry
Total cleared
6
First cleared
Most recent

Market context for product code JGF

FDA has cleared 6 devices under product code JGF between 1986 and 1998, filed by 4 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 JGF

Recent clearances under product code JGF

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