510(k) K233764

SSS-NX (Serum Substitute Supplement-NX) by Fujifilm Irvine Scientific — Product Code MQL

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