This page lists all FDA 510(k) submissions for Instrument, Coagulation, Automated devices (product code GKP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Hematology FDA review panel. Browse all Hematology devices →

Data Source

FDA 510(k) public files . 4,872 total devices indexed.

Latest clearance: Mar 03, 2016

Product Code Info

Code	GKP
Device class	Class II
CFR	21 CFR 864.5400
Panel	Hematology

Verify on FDA.gov

View GKP classification on FDA.gov →