LYRClass I

Helicobacter Pylori

21 CFR 866.3110 / Microbiology

LYR is the FDA product code for Helicobacter Pylori, a class I device type, regulated under 21 CFR 866.3110. As of 2026-09-10, FDA records hold 91 510(k) clearances under this code, the most recent dated 2023-12-15, and 11 recalls.

Classification record

Product code: LYR
Device name: Helicobacter Pylori
Regulation: 21 CFR 866.3110
Device class: Class I
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 91
Ingested recalls: 11

Clearances, product code LYR

By decision year

91 clearances under product code LYR with a decision year between 1988 and 2023, 1998 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code LYR by decision year
Year	Clearances
1988	1
1989	1
1991	10
1992	4
1993	2
1994	2
1995	6
1996	9
1997	6
1998	11
1999	6
2000	5
2001	3
2002	2
2003	5
2004	1
2006	3
2012	2
2015	2
2016	2
2018	4
2019	1
2020	1
2023	2

Applicants with the most clearances

Product code LYR

Applicants holding the most 510(k) clearances under product code LYR
Applicant	Clearances
Meridian Bioscience Inc	6
Ortho-Clinical Diagnostics, Inc.	6
Meridian Diagnostics, Inc.	5
Biomerica	3
bioMerieux, Inc.	2
Chemtrak, Inc.	2
Diasorin Inc.	2
E-Z-EM, Inc	2
Enteric Products, Inc.	2
Gi Supply	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order