The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Anti-hav Assay.
| Device ID | K193532 |
| 510k Number | K193532 |
| Device Name: | LIAISON Anti-HAV Assay |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 |
| Contact | John C. Walter |
| Correspondent | Mari Meyer DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-03-02 |