LYR · Class I · 21 CFR 866.3110

FDA Product Code LYR: Helicobacter Pylori

Leading manufacturers include Meridian Bioscience, Inc., Techlab, Inc. and Diagnostic Products Corp..

91
Total
91
Cleared
165d
Avg days
1988
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Helicobacter Pylori Devices (Product Code LYR)

91 devices
1–24 of 91
Cleared Dec 15, 2023
Hp Detect™ Stool Antigen ELISA
K232892
Biomerica, Inc.
Microbiology · 88d
Cleared Jul 03, 2023
Premier HpSA Flex (619096)
K230901
Meridian Bioscience, Inc.
Microbiology · 94d
Cleared Mar 13, 2020
Curian HpSA, Curian Analyzer
K192817
Meridian Bioscience, Inc.
Microbiology · 164d
Cleared Mar 14, 2019
Vstrip H. pylori Antigen Rapid Test
K183573
Panion & BF Biotech, Inc.
Microbiology · 83d
Cleared Nov 05, 2018
PREMIER Platinum HpSA PLUS
K182559
Meridian Bioscience, Inc.
Microbiology · 49d
Cleared Aug 31, 2018
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
K181464
DiaSorin, Inc.
Microbiology · 88d
Cleared Aug 21, 2018
H. PYLORI QUIK CHEK
K181379
Techlab, Inc.
Microbiology · 89d
Cleared Aug 21, 2018
H. PYLORI CHEK™
K181400
Techlab, Inc.
Microbiology · 84d
Cleared Oct 04, 2000
VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
K001460
bioMerieux, Inc.
Microbiology · 147d
Cleared Jun 01, 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463
Diagnostic Products Corp.
Microbiology · 111d
Cleared Nov 18, 1998
ABBOTT TESTPACK PLUS H. PYLORI
K982362
Abbott Laboratories
Microbiology · 135d
Cleared Mar 03, 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523
Boehringer Mannheim Corp.
Microbiology · 167d

About Product Code LYR - Regulatory Context

510(k) Submission Activity

91 total 510(k) submissions under product code LYR since 1988, with 91 receiving FDA clearance (average review time: 165 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.