The following data is part of a premarket notification filed by Axis-shield Diagnostics, Ltd. with the FDA for Axsym Anti-ccp Reagent, Standard Calibrator And Control Kits, Models 3l91-20, 3l91-01 And 3l91-10.
| Device ID | K063347 |
| 510k Number | K063347 |
| Device Name: | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK Dundee, Scotland, GB Dd2 1xa |
| Contact | Erica Conway |
| Correspondent | Erica Conway 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 | 2006-11-06 |
| Decision Date | 2007-03-20 |
| Summary: | summary |