The following data is part of a premarket notification filed by Euro-diagnostica Ab with the FDA for Edia Anti-ccp.
| Device ID | K062045 |
| 510k Number | K062045 |
| Device Name: | EDIA ANTI-CCP |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | EURO-DIAGNOSTICA AB MEDEON Malmo, SE Se-205 12 |
| Contact | Annika Andersson |
| Correspondent | Annika Andersson EURO-DIAGNOSTICA AB MEDEON Malmo, SE Se-205 12 |
| Product Code | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-19 |
| Decision Date | 2006-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817000294 | K062045 | 000 |
| 07340058410615 | K062045 | 000 |