The following data is part of a premarket notification filed by Sebia with the FDA for Capillarys Hemoglobin Hba1c Capillarys 2 Flex Piercing Capillarys Hba1c Controls Capillarys Hba1c C.
| Device ID | K122101 |
| 510k Number | K122101 |
| Device Name: | CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SEBIA 1705 CORPORATE DRIVE SUITE 400 Duluth, GA 30093 |
| Contact | Karen Anderson |
| Correspondent | Karen Anderson SEBIA 1705 CORPORATE DRIVE SUITE 400 Duluth, GA 30093 |
| Product Code | LCP |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-12-06 |
| Summary: | summary |