K240797 is an FDA 510(k) clearance for the PPH 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 Permantis Public Health (New York, US). The FDA issued a Cleared decision on October 11, 2024, 203 days after receiving the submission on March 22, 2024.
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 | K240797 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2024 |
| Decision Date | October 11, 2024 |
| Days to Decision | 203 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. |