510(k) K233764
K233764 is an FDA 510(k) premarket notification submitted by Fujifilm Irvine Scientific for the device "SSS-NX (Serum Substitute Supplement-NX)". The FDA issued a decision of Substantially Equivalent on April 24, 2024. 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
- April 24, 2024
- Date Received
- November 24, 2023
- 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