The following data is part of a premarket notification filed by Sweden Diagnostics (us), Inc. with the FDA for Elia Ccp, Model 14-5515-01; Elia Ccp Control, Model 83-1009-01.
| Device ID | K061165 |
| 510k Number | K061165 |
| Device Name: | ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | SWEDEN DIAGNOSTICS (US), INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin R Mann |
| Correspondent | Martin R Mann SWEDEN DIAGNOSTICS (US), INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-26 |
| Decision Date | 2006-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010687 | K061165 | 000 |
| 07333066013657 | K061165 | 000 |
| 07333066013640 | K061165 | 000 |
| 07333066001036 | K061165 | 000 |
| 07333066020051 | K061165 | 000 |
| 07333066014173 | K061165 | 000 |
| 07333066020938 | K061165 | 000 |
| 07333066020921 | K061165 | 000 |
| 07333066020914 | K061165 | 000 |
| 07333066013633 | K061165 | 000 |
| 07333066013725 | K061165 | 000 |
| 07333066010656 | K061165 | 000 |
| 07333066010649 | K061165 | 000 |
| 07333066013893 | K061165 | 000 |
| 07333066013848 | K061165 | 000 |
| 07333066013800 | K061165 | 000 |
| 07333066013756 | K061165 | 000 |
| 07333066013749 | K061165 | 000 |
| 07333066013732 | K061165 | 000 |
| 07333066020907 | K061165 | 000 |