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 |