K230675 is an FDA 510(k) clearance for the VITEK REVEAL GN AST Assay and VITEK REVEAL AST System. This device is classified as a Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples (Class II - Special Controls, product code SAN).
Submitted by Specific Diagnostics, LLC (San Jose, US). The FDA issued a Cleared decision on June 20, 2024, 468 days after receiving the submission on March 10, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1650. Automated System That Performs Antimicrobial Susceptibility Testing Using Positive Blood Culture Samples.
| 510(k) Number | K230675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2023 |
| Decision Date | June 20, 2024 |
| Days to Decision | 468 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | SAN - Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1650 |
| Definition | Automated System That Performs Antimicrobial Susceptibility Testing Using Positive Blood Culture Samples |