The following data is part of a premarket notification filed by Sebia with the FDA for Capi 3 Hemoglobin(e).
| Device ID | K180762 |
| 510k Number | K180762 |
| Device Name: | CAPI 3 HEMOGLOBIN(E) |
| Classification | Abnormal Hemoglobin Quantitation |
| 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 | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-23 |
| Decision Date | 2018-12-14 |
| Summary: | summary |