The following data is part of a premarket notification filed by Sebia with the FDA for Capi 3 Hb A1c, Multi-system Hb A1c Capillary Controls (2).
| Device ID | K162281 |
| 510k Number | K162281 |
| Device Name: | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) |
| Classification | Assay, Glycosylated Hemoglobin |
| 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 | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-15 |
| Decision Date | 2017-02-17 |
| Summary: | summary |