Product code DII— Clinical Chemistry

CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY

Classification name
Columns, Glc
Device class
Class 1
Regulation
21 CFR 862.2250
Advisory panel
Clinical Chemistry
Total cleared
5
First cleared
Most recent

Market context for product code DII

FDA has cleared 5 devices under product code DII between 1979 and 1988, filed by 3 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.

Clearances per year

Top applicants under product code DII

Recent clearances under product code DII

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