The following data is part of a premarket notification filed by Sebia with the FDA for Capillarys Hemoglobin, Capillarys Flex Piercing System.
| Device ID | K112550 |
| 510k Number | K112550 |
| Device Name: | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM |
| Classification | Abnormal Hemoglobin Quantitation |
| Applicant | SEBIA 400-1705 CORPORATE DRIVE Norcross, GA 30096 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA 400-1705 CORPORATE DRIVE Norcross, GA 30096 |
| Product Code | GKA |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2012-05-25 |