DeviceClearance

Product code GKR— Hematology

HEMOGLOBIN REAGENT

Classification name
System, Hemoglobin, Automated
Device class
Class 2
Regulation
21 CFR 864.5620
Advisory panel
Hematology
Total cleared
39
First cleared
Most recent

Market context for product code GKR

FDA has cleared 39 devices under product code GKR between 1977 and 2020, filed by 27 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 GKR

Recent clearances under product code GKR

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