The following data is part of a premarket notification filed by Axis-shield Poc As with the FDA for Afinion Lipid Panel And Afinion Lipid Panel Control.
| Device ID | K132031 |
| 510k Number | K132031 |
| Device Name: | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| 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 | CHH |
| Subsequent Product Code | JGY |
| Subsequent Product Code | JJY |
| Subsequent Product Code | LBR |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-18 |
| Decision Date | 2014-03-21 |
| Summary: | summary |