FDA Product Code
FDA Product Code LOL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3310
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics | 2026-04-07 | Traditional | PDF ↗ |
| K251995 | Access anti-HAV IgM | Beckman Coulter, Inc. | 2026-01-27 | Traditional | PDF ↗ |
| K243846 | Access anti-HAV | Beckman Coulter, Inc. | 2025-09-09 | Traditional | PDF ↗ |
| K222850 | HAVAb IgG II | Abbott Laboratories | 2023-08-10 | Traditional | PDF ↗ |
| K223403 | LIAISON Anti-HAV; LIAISON XS | DiaSorin, Inc. | 2022-12-09 | Special | PDF ↗ |
| K210272 | LIAISON Anti-HAV | DiaSorin, Inc. | 2021-02-09 | Special | PDF ↗ |
| K193532 | LIAISON Anti-HAV Assay | DiaSorin, Inc. | 2020-03-02 | Traditional | PDF ↗ |
| K190428 | Elecsys Anti-HAV II | Roche Diagnostics | 2019-08-13 | Traditional | PDF ↗ |
| K161964 | ADVIA Centaur HAV IgM Assay | Siemens Healthcare Diagnostics, Inc. | 2016-10-13 | Traditional | PDF ↗ |
| K160650 | LIAISON HAV IgM, LIAISON Control HAV IgM | DiaSorin, Inc. | 2016-08-25 | Traditional | PDF ↗ |
| K142758 | ADVIA Centaur HAV total assay | Siemens Healthcare Diagnostics, Inc. | 2014-12-05 | Traditional | PDF ↗ |
| K141116 | LIAISON XL ANALYZER | DiaSorin, Inc. | 2014-07-25 | Traditional | PDF ↗ |
| K113704 | ARCHITECT HAVAB-G | Abbott Laboratories | 2012-06-28 | Traditional | PDF ↗ |
| K103529 | LIAISON XL ANALYZER MODEL 10050 | DiaSorin, Inc. | 2011-01-21 | Traditional | PDF ↗ |
| K100903 | ANTI-HAV | Roche Professional Diagnostics | 2010-10-05 | Traditional | PDF ↗ |
| K093955 | ANTI-HAV IGM | Roche Diagnostics | 2010-06-22 | Traditional | PDF ↗ |
| K092353 | MONOLISA ANTI-HAV IGM EIA | Bio-Rad Laboratories, Inc. | 2009-10-29 | Traditional | PDF ↗ |
| K092355 | MONOLISA ANTI-HAV EIA | Bio-Rad Laboratories, Inc. | 2009-10-29 | Traditional | PDF ↗ |
| K082049 | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV | DiaSorin, Inc. | 2008-12-05 | Traditional | PDF ↗ |
| K082050 | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM | DiaSorin, Inc. | 2008-11-03 | Traditional | PDF ↗ |
| K081716 | ADVIA CENTAUR HAVM ASSAY | Siemens Healthcare Diagnostics, Inc. | 2008-07-17 | Special | PDF ↗ |
| K063318 | MONOLISA ANTI-HAV EIA | Bio-Rad Laboratories | 2007-05-03 | Traditional | PDF ↗ |
| K063319 | MONOLISA ANTI-HAV IGM EIA | Bio-Rad Laboratories | 2007-05-03 | Traditional | PDF ↗ |
| K063329 | ABBOTT ARCHITECT HAVAB-M | Abbott Laboratories | 2007-04-16 | Abbreviated | PDF ↗ |
| K060770 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS | Ortho-Clinical Diagnostics, Inc. | 2006-09-15 | Traditional | PDF ↗ |
| K060678 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS | Ortho-Clinical Diagnostics, Inc. | 2006-09-14 | Traditional | PDF ↗ |
Product code LOL · Class II · Microbiology. Data: openFDA.