DeviceClearance

Product code JCG— Hematology

SDI PREPAX COUNTAPETTE KIT

Classification name
Fluid, Diluting, Manual Cell
Device class
Class 1
Regulation
21 CFR 864.8200
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

Market context for product code JCG

FDA has cleared 1 device under product code JCG, all in 1989, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code JCG

Recent clearances under product code JCG

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