The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison H. Pylori Igg, Liaison H. Pylori Igg Control Set.
| Device ID | K161139 |
| 510k Number | K161139 |
| Device Name: | LIAISON H. Pylori IgG, LIAISON H. Pylori IgG Control Set |
| Classification | Helicobacter Pylori |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | John Walter |
| Correspondent | Kelly R. Sauer DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | LYR |
| Subsequent Product Code | JJQ |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-22 |
| Decision Date | 2016-07-22 |
| Summary: | summary |