The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Hav Igm, Liaison Control Hav Igm.
| Device ID | K160650 |
| 510k Number | K160650 |
| Device Name: | LIAISON HAV IgM, LIAISON Control HAV IgM |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285 |
| Contact | John Walter |
| Correspondent | Carol A. Depouw DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285 |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-08 |
| Decision Date | 2016-08-25 |
| Summary: | summary |