The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Xl Analyzer Model 10050.
| Device ID | K103529 |
| 510k Number | K103529 |
| Device Name: | LIAISON XL ANALYZER MODEL 10050 |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | DIASORIN, INC. 195 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | Mari Meyer |
| Correspondent | Mari Meyer DIASORIN, INC. 195 NORTHWESTERN AVE. P.O. BOX 285 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 | 2010-12-01 |
| Decision Date | 2011-01-21 |
| Summary: | summary |