DeviceClearance

Product code MSQ— Microbiology

BreathID Hp Lab System

Classification name
Test, Urea (Breath Or Blood)
Device class
Class 1
Regulation
21 CFR 866.3110
Advisory panel
Microbiology
Total cleared
17
First cleared
Most recent

Market context for product code MSQ

FDA has cleared 17 devices under product code MSQ between 1997 and 2022, filed by 9 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 MSQ

Recent clearances under product code MSQ

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