The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Brahms Pct Ii Gen, Liaison Control Brahms Pct Ii Gen, Liaison Brahms Pct Ii Gen Verifiers.
| Device ID | K173683 |
| 510k Number | K173683 |
| Device Name: | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers |
| Classification | Procalcitonin Assay |
| Applicant | DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082 -0285 |
| Contact | John C Walter |
| Correspondent | Carol A Depouw DiaSorin Inc. 1951 Northwestern Ave. Stillwater, MN 55082 -0285 |
| Product Code | PRI |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NTM |
| Subsequent Product Code | PMT |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-01 |
| Decision Date | 2018-02-27 |
| Summary: | summary |