LIAISON Anti-HAV Assay
FDA 510(k) clearance K193532 · decided 2020-03-02
Clearance details
- K-number
- K193532
- Device name
- LIAISON Anti-HAV Assay
- Applicant
- DiaSorin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-20
- Decision date
- 2020-03-02
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- LOL
- Device class
- 2
- Regulation number
- 866.3310
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch DiaSorin
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HAV IgM (K260048) | Roche Diagnostics | 2026-04-07 |
| Access anti-HAV IgM (K251995) | Beckman Coulter, Inc. | 2026-01-27 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |
| HAVAb IgG II (K222850) | Abbott Laboratories | 2023-08-10 |
| LIAISON Anti-HAV; LIAISON XS (K223403) | DiaSorin, Inc. | 2022-12-09 |
| LIAISON Anti-HAV (K210272) | DiaSorin, Inc. | 2021-02-09 |
| Elecsys Anti-HAV II (K190428) | Roche Diagnostics | 2019-08-13 |
| ADVIA Centaur HAV IgM Assay (K161964) | Siemens Healthcare Diagnostics, Inc. | 2016-10-13 |
| LIAISON HAV IgM, LIAISON Control HAV IgM (K160650) | DiaSorin, Inc. | 2016-08-25 |
| ADVIA Centaur HAV total assay (K142758) | Siemens Healthcare Diagnostics, Inc. | 2014-12-05 |
| LIAISON XL ANALYZER (K141116) | DiaSorin, Inc. | 2014-07-25 |
| ARCHITECT HAVAB-G (K113704) | Abbott Laboratories | 2012-06-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S008) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus (P180047/S041) | DiaSorin, Inc. | 2025-12-19 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021) | DiaSorin, Inc. | 2025-10-10 |