The following data is part of a premarket notification filed by Axis-shield Poc As with the FDA for Afinion Analyzer.
| Device ID | K110056 |
| 510k Number | K110056 |
| Device Name: | AFINION ANALYZER |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | AXIS-SHIELD POC AS P.O. BOX 6863 RODELOKKA Oslo, NO N-0504 |
| Contact | Kari Skinnemoen |
| Correspondent | Kari Skinnemoen AXIS-SHIELD POC AS P.O. BOX 6863 RODELOKKA Oslo, NO N-0504 |
| Product Code | LCP |
| Subsequent Product Code | DCK |
| Subsequent Product Code | JFY |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | JQT |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-10 |
| Decision Date | 2011-02-15 |
| Summary: | summary |