DeviceClearance

Product code GKK— Hematology

CYMET-PLUS

Classification name
Cyanomethemoglobin
Device class
Class 2
Regulation
21 CFR 864.7500
Advisory panel
Hematology
Total cleared
7
First cleared
Most recent

Market context for product code GKK

FDA has cleared 7 devices under product code GKK between 1977 and 1990, filed by 7 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 GKK

Recent clearances under product code GKK

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