DeviceClearance

Product code GIE— Hematology

B4182-1

Classification name
Fibrometer
Device class
Class 2
Regulation
21 CFR 864.5400
Advisory panel
Hematology
Total cleared
2
First cleared
Most recent

Market context for product code GIE

FDA has cleared 2 devices under product code GIE, all in 1982, filed by 1 applicant company. 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 GIE

Recent clearances under product code GIE

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