K233324 is an FDA 510(k) clearance for the Molecular Transport Media - MTM. This device is classified as a Microbial Nucleic Acid Storage And Stabilization Device (Class II - Special Controls, product code QBD).
Submitted by Alb Luz (Valinhos, BR). The FDA issued a Cleared decision on June 17, 2024, 262 days after receiving the submission on September 29, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2950. Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material..
| 510(k) Number | K233324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | June 17, 2024 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QBD - Microbial Nucleic Acid Storage And Stabilization Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2950 |
| Definition | Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material. |