The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Ebv Igm Serum Control Set.
| Device ID | K161522 |
| 510k Number | K161522 |
| Device Name: | LIAISON EBV IgM Serum Control Set |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | DiaSorin Inc. 1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082 -0285 |
| Contact | John Walter |
| Correspondent | Sandra Zimniewicz DiaSorin Inc. 1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082 -0285 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-02 |
| Decision Date | 2016-06-30 |