The following data is part of a premarket notification filed by Sebia with the FDA for Capillarys Hb A1c.
| Device ID | K171861 |
| 510k Number | K171861 |
| Device Name: | CAPILLARYS Hb A1c |
| Classification | Hemoglobin A1c Test System |
| Applicant | Sebia 1705 Corporate Drive Suite 400 Norcross, GA 30093 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson Sebia 1705 Corporate Drive Suite 400 Norcross, GA 30093 |
| Product Code | PDJ |
| CFR Regulation Number | 862.1373 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-22 |
| Decision Date | 2018-02-07 |
| Summary: | summary |