Product code GKX— Hematology
ABX MICROS 60 HEMATOLOGY ANALYZER
- Classification name
- Instrument, Automated Platelet Counting
- Device class
- Class 2
- Regulation
- 21 CFR 864.5200
- Advisory panel
- Hematology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GKX
FDA has cleared devices under product code GKX between 1984 and 2002, filed by 2 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
- 2002
- 1984
Top applicants under product code GKX
Recent clearances under product code GKX
Data sourced from openFDA. This site is unofficial and independent of the FDA.