510(k) K221547
K221547 is an FDA 510(k) premarket notification submitted by Fertipro NV for the device "InActiv Blue". The FDA issued a decision of Substantially Equivalent on June 11, 2024. The device falls under product code QBD (Microbial Nucleic Acid Storage And Stabilization Device), a Class II device regulated under 21 CFR 866.2950. Fertipro NV has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2024
- Date Received
- May 27, 2022
- 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.