DeviceClearance

Product code GKF— Hematology

CHEMPRO 1000(TM)

Classification name
Instrument, Hematocrit, Automated
Device class
Class 2
Regulation
21 CFR 864.5600
Advisory panel
Hematology
Total cleared
15
First cleared
Most recent

Market context for product code GKF

FDA has cleared 15 devices under product code GKF between 1978 and 2016, filed by 12 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 GKF

Recent clearances under product code GKF

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