The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Memed Bv, Liaison Memed Bv Control Set.
| Device ID | K213936 |
| 510k Number | K213936 |
| Device Name: | LIAISON MeMed BV, LIAISON MeMed BV Control Set |
| Classification | Immunoassay For Host Biomarkers Of Infection |
| Applicant | DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285 |
| Contact | John C. Walter |
| Correspondent | Emily Peterson DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 -0285 |
| Product Code | QPS |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-16 |
| Decision Date | 2022-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056771602976 | K213936 | 000 |
| 08056771602969 | K213936 | 000 |