DeviceClearance

Product code LYR— Microbiology

ACCUMETER H. PYLORI TEST

Classification name
Helicobacter Pylori
Device class
Class 1
Regulation
21 CFR 866.3110
Advisory panel
Microbiology
Total cleared
91
First cleared
Most recent

Market context for product code LYR

FDA has cleared 91 devices under product code LYR between 1988 and 2023, filed by 59 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

last 15 years

Top applicants under product code LYR

Adverse events under product code LYR

product code LYR
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LYR

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