Product code DOP— Clinical Chemistry

ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS

Classification name
Mass Spectrometer, Clinical Use
Device class
Class 1
Regulation
21 CFR 862.2860
Advisory panel
Clinical Chemistry
Total cleared
10
First cleared
Most recent

Market context for product code DOP

FDA has cleared 10 devices under product code DOP between 1977 and 1999, filed by 7 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 DOP

Recent clearances under product code DOP

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