K233606 is an FDA 510(k) clearance for the ADVIA Centaur EBV-VCA IgM. This device is classified as a Epstein-barr Virus, Other (Class I - General Controls, product code LSE).
Submitted by Biokit, S.A. (Lliçà D’Amunt, Barcelona, ES). The FDA issued a Cleared decision on August 7, 2024, 272 days after receiving the submission on November 9, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K233606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2023 |
| Decision Date | August 07, 2024 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSE — Epstein-barr Virus, Other |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |