The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Axis-shield Acvtive-b12.
| Device ID | K121946 |
| 510k Number | K121946 |
| Device Name: | AXIS-SHIELD ACVTIVE-B12 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK, LUNA PLACE Dundee, Scotland, GB Dd2 1xa |
| Contact | Simon John Richards |
| Correspondent | Simon John Richards AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK, LUNA PLACE Dundee, Scotland, GB Dd2 1xa |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-03 |
| Decision Date | 2013-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055845400046 | K121946 | 000 |