The following data is part of a premarket notification filed by Alere Technologies As with the FDA for Afinion Hba1c Dx On Afinion 2.
| Device ID | K182988 |
| 510k Number | K182988 |
| Device Name: | Afinion HbA1c Dx On Afinion 2 |
| Classification | Hemoglobin A1c Test System |
| Applicant | Alere Technologies AS Kjelsaasveien 161 Oslo, NO No-0884 |
| Contact | Monica Vallestad |
| Correspondent | Monica Vallestad Alere Technologies AS Kjelsaasveien 161 Oslo, NO No-0884 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-29 |
| Decision Date | 2018-11-29 |
| Summary: | summary |