The following data is part of a premarket notification filed by Sebia with the FDA for Minicap Immunotyping Using The Minicap And The Minicap Flex-piercing.
| Device ID | K143483 |
| 510k Number | K143483 |
| Device Name: | MINICAP Immunotyping Using The MINICAP And The MINICAP FLEX-PIERCING |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| 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 | CFF |
| Subsequent Product Code | CEF |
| Subsequent Product Code | DEH |
| Subsequent Product Code | DFH |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-08 |
| Decision Date | 2015-01-08 |
| Summary: | summary |