DeviceClearance

Product code GLQ— Hematology

STAK-CHEX PLUS RETICS

Classification name
Mixture, Control, White-Cell And Red-Cell Indices
Device class
Class 2
Regulation
21 CFR 864.8625
Advisory panel
Hematology
Total cleared
10
First cleared
Most recent

Market context for product code GLQ

FDA has cleared 10 devices under product code GLQ between 1982 and 2011, 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 GLQ

Recent clearances under product code GLQ

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