FDA 510(k)

SSS-NX (Serum Substitute Supplement-NX)

K-Number: K233764 · 2024-04-24

Decision Date2024-04-24

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SSS-NX (Serum Substitute Supplement-NX) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Irvine Scientific. It received FDA 510(k) clearance on 2024-04-24 under 510(k) number K233764. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SSS-NX (Serum Substitute Supplement-NX)?

SSS-NX (Serum Substitute Supplement-NX) is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Fujifilm Irvine Scientific. The 510(k) number is K233764.

When did SSS-NX (Serum Substitute Supplement-NX) receive FDA 510(k) clearance?

SSS-NX (Serum Substitute Supplement-NX) received FDA 510(k) clearance on 2024-04-24, under 510(k) number K233764.

Who is the listed applicant for SSS-NX (Serum Substitute Supplement-NX)?

The FDA 510(k) record lists Fujifilm Irvine Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SSS-NX (Serum Substitute Supplement-NX)?

The FDA product code for SSS-NX (Serum Substitute Supplement-NX) is MQL.

Other records listing Fujifilm Irvine Scientific as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250445Fast Warm - NX K241341cryo-GO Vitrification Device K231804PRIME-XV FreezIS DMSO-Free MD K190152Vit Kit- Freeze NX and Vit Kit- Warm NX

Related Devices (Code: MQL)

K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.