The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Helicobacter Antigen, Liaison Helicobacter Antigen Control Set.
| Device ID | K181464 |
| 510k Number | K181464 |
| Device Name: | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set |
| Classification | Helicobacter Pylori |
| Applicant | DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082 -0285 |
| Contact | John C. Walter |
| Correspondent | Sandra Zimniewicz DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082 -0285 |
| Product Code | LYR |
| Subsequent Product Code | JJF |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2018-08-31 |
| Summary: | summary |