The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Diastat Anti Cyclic Citrullinated Peptide (anti-ccp) Elisa.
| Device ID | K023285 |
| 510k Number | K023285 |
| Device Name: | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Contact | Eileen Mccafferty |
| Correspondent | Eileen Mccafferty AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK 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 | 2002-09-16 |
| Decision Date | 2002-10-09 |