DeviceClearance

Product code GGL— Hematology

CD-CHEX

Classification name
Control, White-Cell
Device class
Class 2
Regulation
21 CFR 864.8625
Advisory panel
Hematology
Total cleared
8
First cleared
Most recent

Market context for product code GGL

FDA has cleared 8 devices under product code GGL between 1989 and 2009, 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 GGL

Recent clearances under product code GGL

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