K082388 is an FDA 510(k) clearance for the MINICAP IMMUNOTYPING, MODEL: 2300. 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 April 14, 2009, 238 days after receiving the submission on August 19, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K082388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2008 |
| Decision Date | April 14, 2009 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |