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 |