DeviceClearance

Product code JKT— Clinical Toxicology

BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-

Classification name
Gas Chromatograph, Carbon-Monoxide
Device class
Class 1
Regulation
21 CFR 862.3220
Advisory panel
Clinical Toxicology
Total cleared
2
First cleared
Most recent

Market context for product code JKT

FDA has cleared 2 devices under product code JKT, all in 1983, filed by 2 applicant companies. 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 JKT

Recent clearances under product code JKT

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