FDA 510(k) Applications for Medical Device Product Code "LYR"
(Campylobacter Pylori)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K982362 | ABBOTT LABORATORIES | ABBOTT TESTPACK PLUS H. PYLORI | 11/18/1998 |
| K024350 | ACON LABORATORIES, INC. | ACON H. PYLORI RAPID TEST STRIP AND ACON H. PYLORI RAPID TEST DEVICE | 04/02/2003 |
| K151935 | ALERE SAN DIEGO, INCORPORATED | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only | 08/12/2015 |
| K024360 | ALFA SCIENTIFIC DESIGNS, INC. | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | 06/10/2003 |
| K981396 | AMDL, INC. | PYLORIPROBE | 07/30/1998 |
| K052708 | ARJ MEDICAL, INC. | PYLO-PLUS | 05/01/2006 |
| K961221 | ARMKEL, LLC. | PYLORI IGG ELISA TEST SYSTEM | 07/30/1996 |
| K041238 | BIOHIT PLC | HELICOBACTER PYLORI IGG ELISA | 12/13/2004 |
| K141133 | BIOMERIEUX | 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 | 07/09/2015 |
| K001460 | BIOMERIEUX, INC. | VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 | 10/04/2000 |
| K973523 | BOEHRINGER MANNHEIM CORP. | ACCUSTAT H. PYLORI ONE STEP TEST | 03/03/1998 |
| K960478 | CHEMTRAK, INC. | ACCUMETER H. PYLORI TEST | 06/27/1996 |
| K965099 | CHEMTRAK, INC. | ACCUMETER H. PYLORI TEST | 02/20/1997 |
| K990462 | COLUMBIA BIOSCIENCE, INC. | IS H. PYLORI IGG ELISA TEST SYSTEM | 09/03/1999 |
| K972146 | CONSOLIDATED TECHNOLOGIES, INC. | QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS | 07/08/1997 |
| K953686 | CORTECS, LTD. | HELISAL RAPID BLOOD TEST | 05/21/1996 |
| K000463 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG | 06/01/2000 |
| K181464 | DiaSorin Inc. | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | 08/31/2018 |
| K161139 | DIASORIN, INC. | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | 07/22/2016 |
| K954926 | E-Z-EM, INC. | HM-CAP CONTROL PANEL | 01/30/1996 |
| K953873 | ELIAS USA, INC. | VARELISA HELICOBACTER PYLORI ANTIBODIES | 08/30/1996 |
| K001177 | ENTERIC PRODUCTS, INC. | PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI | 11/13/2000 |
| K984544 | ENTERIC PRODUCTS, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S | 02/18/1999 |
| K012411 | GI SUPPLY | HP-ONE | 09/25/2001 |
| K110899 | GOLD STANDARD DIAGNOSTICS | GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT | 02/01/2012 |
| K110745 | GOLD STANDARD DIAGNOSTICS | HELICOBACTER PYLORI ELISA IGG TEST KIT | 03/02/2012 |
| K982790 | INOVA DIAGNOSTICS, INC. | QUANTA LITE H. PYLORI IGG ELISA | 11/04/1998 |
| K024334 | INOVA DIAGNOSTICS, INC. | QUANTA LITE H.PYLORI IGA ELISA | 03/27/2003 |
| K964014 | KENLOR INDUSTRIES, INC. | KENLOR H. PYLORI CONTROL SERUM | 03/03/1997 |
| K991248 | MEDICAL INSTRUMENTS CORPORATION MIC AG | PRONTO DRY | 06/22/1999 |
| K002451 | MEDICAL INSTRUMENTS CORPORATION, AG | MODIFICATION TO: PRONTO DRY | 09/29/2000 |
| K002023 | MEDMIRA LABORATORIES, INC. | MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 | 11/13/2000 |
| K952220 | MERETEK DIAGNOSTICS, INC. | MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT | 09/17/1996 |
| K153661 | Meridian Bioscience, Inc | ImmunoCard STAT! HpSA | 03/14/2016 |
| K192817 | Meridian Bioscience, Inc. | Curian HpSA, Curian Analyzer | 03/13/2020 |
| K032222 | MERIDIAN BIOSCIENCE, INC. | IMMUNOCARDSTAT HPSA | 12/05/2003 |
| K230901 | Meridian Bioscience, Inc. | Premier HpSA Flex (619096) | 07/03/2023 |
| K182559 | Meridian Bioscience, Inc. | PREMIER Platinum HpSA PLUS | 11/05/2018 |
| K053335 | MERIDIAN BIOSCIENCE, INC. | PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 | 03/10/2006 |
| K961508 | MERIDIAN DIAGNOSTICS, INC. | IMMUNOCARD H. PYLORI | 01/21/1997 |
| K983255 | MERIDIAN DIAGNOSTICS, INC. | MODIFICATION TO: PREMIER PLATINUM HPSA | 12/17/1998 |
| K980076 | MERIDIAN DIAGNOSTICS, INC. | PREMIER PLATINUM HPSA | 05/12/1998 |
| K003794 | MICRO DETECT, INC. | ELISA TEST, SEROLOGY | 03/30/2001 |
| K973508 | MICRO DETECT, INC. | PYLORI DETECT IGG | 03/10/1998 |
| K022356 | NICHOLS INSTITUTE DIAGNOSTICS | NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY | 10/25/2002 |
| K971537 | ORION DIAGNOSTICA, DIV. ORION CORP. | PYLORISET EIA-G (68926) | 06/27/1997 |
| K052716 | OTSUKA PHARMACEUTICAL CO., LTD. | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT | 11/16/2006 |
| K012588 | OXOID, LTD. | OXOID PYLORI TEST KIT, MODEL DR0130M | 12/10/2001 |
| K183573 | Panion & BF Biotech Inc. | Vstrip H. pylori Antigen Rapid Test | 03/14/2019 |
| K980798 | PRINCETON BIOMEDITECH CORP. | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST | 09/22/1998 |
| K964675 | PYRAMID BIOLOGICAL CORP. | H.PYLORI CONTROLS | 01/27/1997 |
| K991747 | QUIDEL CORP. | QUICKVUE ONE-STEP H. PYLORI II TEST | 08/04/1999 |
| K952517 | QUIDEL CORP. | QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST | 02/06/1996 |
| K980782 | SALIVA DIAGNOSTIC SYSTEMS, INC. | STAT-SIMPLE PYLORI | 08/05/1998 |
| K955085 | SCHIFF & CO. | HM-CAP EIA TEST (MODIFICATION) | 02/09/1996 |
| K014038 | SERIM RESEARCH CORP. | PYLORITEK VP TEST KIT 5140VP | 02/08/2002 |
| K972981 | SHIELD DIAGNOSTICS, LTD. | SHIELD HELICO-G2 ELISA KIT | 03/17/1998 |
| K960183 | SMITH KLINE DIAGNOSTICS, INC. | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) | 06/07/1996 |
| K181400 | TECHLAB, Inc. | H. PYLORI CHEKÖ | 08/21/2018 |
| K181379 | TECHLAB, Inc. | H. PYLORI QUIK CHEK | 08/21/2018 |
| K033067 | TRINITY BIOTECH USA | PYLORI IGG | 11/26/2003 |
| K991697 | TRINITY BIOTECH, PLC | UNI-GOLD H. PYLORI | 12/21/1999 |
| K980821 | ZEUS SCIENTIFIC, INC. | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM | 07/30/1998 |
| K991820 | ZEUS SCIENTIFIC, INC. | HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI | 08/12/1999 |
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