The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Xl Hcg.
| Device ID | K131037 |
| 510k Number | K131037 |
| Device Name: | LIAISON XL HCG |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Mari Meyer |
| Correspondent | Mari Meyer DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-15 |
| Decision Date | 2013-09-06 |
| Summary: | summary |