510(k) K231013
K231013 is an FDA 510(k) premarket notification submitted by Zymo Research for the device "DNA/RNA Shield SafeCollect Saliva Collection kit". The FDA issued a decision of Substantially Equivalent on September 28, 2023. The device falls under product code QBD (Microbial Nucleic Acid Storage And Stabilization Device), a Class II device regulated under 21 CFR 866.2950. Zymo Research has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2023
- Date Received
- April 10, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Microbial Nucleic Acid Storage And Stabilization Device
- Device Class
- Class II
- Regulation Number
- 866.2950
- Review Panel
- MI
- Submission Type
Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.