FDA 510(k) Applications for Medical Device Product Code "LOL"
(Hepatitis A Test (Antibody And Igm Antibody))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K063329 | ABBOTT LABORATORIES | ABBOTT ARCHITECT HAVAB-M | 04/16/2007 |
| K113704 | ABBOTT LABORATORIES | ARCHITECT HAVAB-G | 06/28/2012 |
| K222850 | ABBOTT LABORATORIES | HAVAb IgG II | 08/10/2023 |
| K063318 | Bio-Rad Laboratories | MONOLISA ANTI-HAV EIA | 05/03/2007 |
| K063319 | Bio-Rad Laboratories | MONOLISA ANTI-HAV IGM EIA | 05/03/2007 |
| K092355 | BIO-RAD LABORATORIES, INC. | MONOLISA ANTI-HAV EIA | 10/29/2009 |
| K092353 | BIO-RAD LABORATORIES, INC. | MONOLISA ANTI-HAV IGM EIA | 10/29/2009 |
| K210272 | DiaSorin Inc. | LIAISON Anti-HAV | 02/09/2021 |
| K193532 | DiaSorin Inc. | LIAISON Anti-HAV Assay | 03/02/2020 |
| K223403 | DiaSorin Inc. | LIAISON Anti-HAV; LIAISON XS | 12/09/2022 |
| K160650 | DiaSorin Inc. | LIAISON HAV IgM, LIAISON Control HAV IgM | 08/25/2016 |
| K082049 | DIASORIN, INC. | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV | 12/05/2008 |
| K082050 | DIASORIN, INC. | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM | 11/03/2008 |
| K141116 | DIASORIN, INC. | LIAISON XL ANALYZER | 07/25/2014 |
| K103529 | DIASORIN, INC. | LIAISON XL ANALYZER MODEL 10050 | 01/21/2011 |
| K060770 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS | 09/15/2006 |
| K060678 | Ortho-Clinical Diagnostics, Inc. | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS | 09/14/2006 |
| K093955 | Roche Diagnostics | ANTI-HAV IGM | 06/22/2010 |
| K190428 | Roche Diagnostics | Elecsys Anti-HAV II | 08/13/2019 |
| K100903 | ROCHE PROFESSIONAL DIAGNOSTICS | ANTI-HAV | 10/05/2010 |
| K081716 | Siemens Healthcare Diagnostics Inc. | ADVIA CENTAUR HAVM ASSAY | 07/17/2008 |
| K161964 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur HAV IgM Assay | 10/13/2016 |
| K142758 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ADVIA Centaur HAV total assay | 12/05/2014 |
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