DeviceClearance

Product code KQJ— Hematology

FIBRINOGEN ASSAY KIT

Classification name
System, Fibrinogen Determination
Device class
Class 2
Regulation
21 CFR 864.7340
Advisory panel
Hematology
Total cleared
28
First cleared
Most recent

Market context for product code KQJ

FDA has cleared 28 devices under product code KQJ between 1980 and 2025, filed by 24 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 KQJ

Recent clearances under product code KQJ

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