510(k) K250445
K250445 is an FDA 510(k) premarket notification submitted by Fujifilm Irvine Scientific for the device "Fast Warm - NX". The FDA issued a decision of Substantially Equivalent on September 12, 2025. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Fujifilm Irvine Scientific has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2025
- Date Received
- February 14, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type