The following data is part of a premarket notification filed by Alere Technologies As with the FDA for Alere Afinion Hba1c, Alere Afinion As100 Analyzer.
| Device ID | K151809 |
| 510k Number | K151809 |
| Device Name: | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Alere Technologies AS KJELSAASVEIEN 161 Oslo, NO No-0884 |
| Contact | Kari Skinnemoen |
| Correspondent | Kari Skinnemoen Alere Technologies AS KJELSAASVEIEN 161 Oslo, NO No-0884 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-02 |
| Decision Date | 2015-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07070060008042 | K151809 | 000 |