DeviceClearance

Product code KHG— Hematology

HEMOGLOBIN REAGENT

Classification name
Whole Blood Hemoglobin Determination
Device class
Class 2
Regulation
21 CFR 864.7500
Advisory panel
Hematology
Total cleared
39
First cleared
Most recent

Market context for product code KHG

FDA has cleared 39 devices under product code KHG between 1976 and 2023, filed by 32 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 KHG

Recent clearances under product code KHG

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