Product code GHY— Hematology

MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL

Classification name
Hematocrit, Tube, Rack, Sealer, Holder
Device class
Class 2
Regulation
21 CFR 864.6400
Advisory panel
Hematology
Total cleared
2
First cleared
Most recent

Market context for product code GHY

FDA has cleared 2 devices under product code GHY, all in 1988, 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.

Top applicants under product code GHY

Recent clearances under product code GHY

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