The following data is part of a premarket notification filed by Abbott Rapid Diagnostics with the FDA for Alere Afinion Hba1c And Acr On Afinion 2 Analyzer.
| Device ID | K171650 |
| 510k Number | K171650 |
| Device Name: | Alere Afinion HbA1c And ACR On Afinion 2 Analyzer |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Abbott Rapid Diagnostics 9975 Summers Ridge Road San Diego, CA 92121 |
| Contact | Monica Vallestad |
| Correspondent | Annie Wright Abbott Rapid Diagnostics 9975 Summers Ridge Road San Diego, CA 92121 |
| Product Code | LCP |
| Subsequent Product Code | JFY |
| Subsequent Product Code | JQT |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-05 |
| Decision Date | 2017-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07070060014654 | K171650 | 000 |
| 07070060014630 | K171650 | 000 |