The following data is part of a premarket notification filed by Sebia with the FDA for Minicap Hb A1c, Minicap Flex-piercing, Hb A1c Capillarys Controls, Hba1c Capillarys Calibrators.
| Device ID | K133344 |
| 510k Number | K133344 |
| Device Name: | MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS |
| 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 |
| 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 | 2013-10-30 |
| Decision Date | 2014-03-28 |
| Summary: | summary |