The following data is part of a premarket notification filed by Sebia with the FDA for Capi 3 Immunotyping, Capillarys 3 Tera, It/if Control.
| Device ID | K161928 |
| 510k Number | K161928 |
| Device Name: | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL |
| 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 |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-14 |
| Decision Date | 2016-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607360026021 | K161928 | 000 |
| 03607360026014 | K161928 | 000 |