LYR · Class I · 21 CFR 866.3110

FDA Product Code LYR: Helicobacter Pylori

Leading manufacturers include Meridian Bioscience, Inc., Quidel Corp. and Meridian Diagnostics, Inc..

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 Jul 22, 2016
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
K161139
DiaSorin, Inc.
Microbiology · 91d
Cleared Mar 14, 2016
ImmunoCard STAT! HpSA
K153661
Meridian Bioscience, Inc.
Microbiology · 84d
Cleared Mar 10, 2006
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335
Meridian Bioscience, Inc.
Microbiology · 99d
Cleared Dec 05, 2003
IMMUNOCARDSTAT HPSA
K032222
Meridian Bioscience, Inc.
Microbiology · 137d
Cleared Jun 10, 2003
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
K024360
Alfa Scientific Designs, Inc.
Microbiology · 162d
Cleared Apr 02, 2003
ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE
K024350
ACON Laboratories, Inc.
Microbiology · 93d
Cleared Mar 27, 2003
QUANTA LITE H.PYLORI IGA ELISA
K024334
Inova Diagnostics, Inc.
Microbiology · 91d
Cleared Oct 25, 2002
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
K022356
Nichols Institute Diagnostics
Microbiology · 98d
Cleared Dec 10, 2001
OXOID PYLORI TEST KIT, MODEL DR0130M
K012588
Oxoid , Ltd.
Microbiology · 122d
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 Aug 12, 1999
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
K991820
Zeus Scientific, Inc.
Microbiology · 77d
Cleared Aug 04, 1999
QUICKVUE ONE-STEP H. PYLORI II TEST
K991747
Quidel Corp.
Microbiology · 75d
Cleared Dec 17, 1998
MODIFICATION TO: PREMIER PLATINUM HPSA
K983255
Meridian Diagnostics, Inc.
Microbiology · 93d
Cleared Nov 18, 1998
ABBOTT TESTPACK PLUS H. PYLORI
K982362
Abbott Laboratories
Microbiology · 135d
Cleared Nov 04, 1998
QUANTA LITE H. PYLORI IGG ELISA
K982790
Inova Diagnostics, Inc.
Microbiology · 86d

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.