The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Vitamin B12.
| Device ID | K192064 |
| 510k Number | K192064 |
| Device Name: | LIAISON Vitamin B12 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | DiaSorin Inc. 1951 Northwestern Ave Stillwater, MN 55082 -0285 |
| Contact | John C. Walter |
| Correspondent | Mari Meyer DiaSorin Inc. 1951 Northwestern Ave, P.O. Box 285 Stillwater, MN 55082 -0285 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-01 |
| Decision Date | 2019-10-02 |