The following data is part of a premarket notification filed by Axis-shield Diagnostics Ltd. with the FDA for Advia Centaur Active-b12 (holotranscobalamin) (ab12) Assay.
| Device ID | K172133 |
| 510k Number | K172133 |
| Device Name: | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay |
| Classification | Radioassay, Vitamin B12 |
| Applicant | Axis-Shield Diagnostics Ltd. Luna Place The Technology Park Dundee, GB Dd2 1xa |
| Contact | Claire Dora |
| Correspondent | Claire Dora Axis-Shield Diagnostics Ltd. Luna Place The Technology Park Dundee, GB Dd2 1xa |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-14 |
| Decision Date | 2017-10-27 |
| Summary: | summary |