The following data is part of a premarket notification filed by Axis-shield Poc As with the FDA for Afinion Acr And Acr Control.
| Device ID | K072409 |
| 510k Number | K072409 |
| Device Name: | AFINION ACR AND ACR CONTROL |
| Classification | Enzymatic Method, Creatinine |
| Applicant | AXIS-SHIELD POC AS MARSTRANDGATA 6 PO BOX 6863 Rodelokka, Oslo, NO N-0504 |
| Contact | Jorunn Grevie Lolland |
| Correspondent | Jorunn Grevie Lolland AXIS-SHIELD POC AS MARSTRANDGATA 6 PO BOX 6863 Rodelokka, Oslo, NO N-0504 |
| Product Code | JFY |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-27 |
| Decision Date | 2008-02-12 |
| Summary: | summary |