LYR

Helicobacter Pylori

Product code: LYR
Device name: Helicobacter Pylori
Device class: Class 1
21 CFR: 21 CFR 866.3110
Medical specialty: Microbiology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 91 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-15.

Number	Decision date	Applicant	Device name	Summary
K232892	2023-12-15	Biomerica, Inc.	Hp Detect Stool Antigen ELISA	PDF

1 summaries are archived here for direct download.

Official FDA classification page: LYR

Classification and pathway per current FDA publications. Data from openFDA (CC0).