LYR · Class I · 21 CFR 866.3110

FDA Product Code LYR: Helicobacter Pylori

Leading manufacturers include Quidel Corp., Meridian Bioscience, Inc. 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 Aug 12, 2015
Alere Signify H. pylori Whole Blood, Serum, Plasma
K151935
Alere San Diego, Incorporated
Microbiology · 29d
Cleared Jul 09, 2015
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II
K141133
BIOMERIEUX
Microbiology · 434d
Cleared Mar 02, 2012
HELICOBACTER PYLORI ELISA IGG TEST KIT
K110745
Gold Standard Diagnostics
Microbiology · 351d
Cleared Feb 01, 2012
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
K110899
Gold Standard Diagnostics
Microbiology · 308d
Cleared Nov 16, 2006
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
K052716
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 413d
Cleared May 01, 2006
PYLO-PLUS
K052708
Arj Medical, Inc.
Microbiology · 214d
Cleared Mar 10, 2006
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K053335
Meridian Bioscience, Inc.
Microbiology · 99d
Cleared Dec 13, 2004
HELICOBACTER PYLORI IGG ELISA
K041238
Biohit Plc
Microbiology · 216d
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 Feb 08, 2002
PYLORITEK VP TEST KIT 5140VP
K014038
Serim Research Corp.
Microbiology · 63d

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.