DeviceClearance

Product code GKP— Hematology

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

Classification name
Instrument, Coagulation, Automated
Device class
Class 2
Regulation
21 CFR 864.5400
Advisory panel
Hematology
Total cleared
49
First cleared
Most recent

Market context for product code GKP

FDA has cleared 49 devices under product code GKP between 1982 and 2024, filed by 18 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 GKP

Recent clearances under product code GKP

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