The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Architect Active B-12 (holotranscobalamin).
| Device ID | K112443 |
| 510k Number | K112443 |
| Device Name: | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) |
| Classification | Radioassay, Vitamin B12 |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee,, GB Dd2 1xa |
| Contact | Claire I Dora |
| Correspondent | Claire I Dora AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee,, GB Dd2 1xa |
| Product Code | CDD |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2011-12-19 |
| Summary: | summary |