DeviceClearance

Product code GKA— Hematology

BIO-RAD VARIANT NBS SICKLE CELL PROGRAM

Classification name
Abnormal Hemoglobin Quantitation
Device class
Class 2
Regulation
21 CFR 864.7415
Advisory panel
Hematology
Total cleared
23
First cleared
Most recent

Market context for product code GKA

FDA has cleared 23 devices under product code GKA between 1981 and 2024, filed by 13 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

last 15 years

Top applicants under product code GKA

Recent clearances under product code GKA

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