The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Architect Anti-ccp (100 Test), Architect Anti-ccp (500 Test), Models 1p65-25, 1p65-35.
| Device ID | K083868 |
| 510k Number | K083868 |
| Device Name: | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Contact | Claire Dora |
| Correspondent | Claire Dora AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Product Code | NHX |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-29 |
| Decision Date | 2009-09-25 |