The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Axis-shield Anti-ccp.
Device ID | K110296 |
510k Number | K110296 |
Device Name: | AXIS-SHIELD ANTI-CCP |
Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee, Scotland, GB Dd2 1xa |
Contact | Claire I Dora |
Correspondent | Claire I Dora AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK LUNA PLACE Dundee, Scotland, GB Dd2 1xa |
Product Code | NHX |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-02-01 |
Decision Date | 2011-08-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05055845400008 | K110296 | 000 |