Submission Details
| 510(k) Number | K210511 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
InTray GC
Oct 2021
Decision
239d
Days
Class 2
Risk
About This 510(k) Submission
K210511 is an FDA 510(k) clearance for the InTray GC, 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 review panel. Regulated under 21 CFR 866.2410.
Device Classification
| Product Code | JTY — Culture Media, For Isolation Of Pathogenic Neisseria |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.2410 |
Manufacturer
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