The following data is part of a premarket notification filed by Alere Technologies As with the FDA for Afinion Hba1c Dx.
| Device ID | K180296 |
| 510k Number | K180296 |
| Device Name: | Afinion HbA1c Dx |
| Classification | Hemoglobin A1c Test System |
| Applicant | Alere Technologies AS Kjelsaasveien 161 Oslo, NO No-0884 |
| Contact | Monica Vallestad |
| Correspondent | Annie Wright Alere Technologies AS Kjelsaasveien 161 PO Box 6863 Rodeloekka No-0504 Oslo, NO |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-02 |
| Decision Date | 2018-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07070060012889 | K180296 | 000 |