K192095 is an FDA 510(k) clearance for the CAPI 3 Immunotyping, Capillarys 3 Tera. This device is classified as a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II - Special Controls, product code CFF).
Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on November 1, 2019, 88 days after receiving the submission on August 5, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K192095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2019 |
| Decision Date | November 01, 2019 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |