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 |