K221664 is an FDA 510(k) clearance for the CLEARinse CTS Specimen Collection and Transport System. This device is classified as a Microbial Nucleic Acid Storage And Stabilization Device (Class II - Special Controls, product code QBD).
Submitted by Aardvark Medical, Inc. (Ross, US). The FDA issued a Cleared decision on July 3, 2023, 390 days after receiving the submission on June 8, 2022.
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 | K221664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2022 |
| Decision Date | July 03, 2023 |
| Days to Decision | 390 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. |