The following data is part of a premarket notification filed by Sebia with the FDA for Sebia Capillarys Hemoglobin(e) With Capillarys 2.
| Device ID | K112491 |
| 510k Number | K112491 |
| Device Name: | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | SEBIA PARC TECHNOLOGIQUE LEONARD DE VINCI Evry, FR 91008 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA PARC TECHNOLOGIQUE LEONARD DE VINCI Evry, FR 91008 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-29 |
| Decision Date | 2012-05-24 |