DeviceClearance

Product code JCO— Hematology

ATROXIN

Classification name
Bothrops Atrox Reagent
Device class
Class 2
Regulation
21 CFR 864.8100
Advisory panel
Hematology
Total cleared
7
First cleared
Most recent

Market context for product code JCO

FDA has cleared 7 devices under product code JCO between 1978 and 1996, filed by 6 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

Top applicants under product code JCO

Recent clearances under product code JCO

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