K231013 is an FDA 510(k) clearance for the DNA/RNA Shield SafeCollect Saliva Collection kit. This device is classified as a Microbial Nucleic Acid Storage And Stabilization Device (Class II - Special Controls, product code QBD).
Submitted by Zymo Research (Irvine, US). The FDA issued a Cleared decision on September 28, 2023, 171 days after receiving the submission on April 10, 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 | K231013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2023 |
| Decision Date | September 28, 2023 |
| Days to Decision | 171 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. |