K210511 is an FDA 510(k) clearance for the InTray GC. This device is classified as a Culture Media, For Isolation Of Pathogenic Neisseria (Class II - Special Controls, product code JTY).
Submitted by Biomed Diagnostics Incorporated (White City, US). The FDA issued a Cleared decision on October 20, 2021, 239 days after receiving the submission on February 23, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2410.
| 510(k) Number | K210511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2021 |
| Decision Date | October 20, 2021 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JTY - Culture Media, For Isolation Of Pathogenic Neisseria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2410 |