The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Hav Igm Assay, Liaison Control Hav Igm.
| Device ID | K082050 |
| 510k Number | K082050 |
| Device Name: | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Carol A Depouw |
| Correspondent | Carol A Depouw DIASORIN, INC. 1951 NORTHWESTERN AVE. 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 | 2008-07-18 |
| Decision Date | 2008-11-03 |
| Summary: | summary |