FDA 510(k)

Continuous Single Culture -NX (CSCM-NX)

K-Number: K170681 · 2017-06-08

ApplicantIrvine Scientific Sales Co., Inc.

Decision Date2017-06-08

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Continuous Single Culture -NX (CSCM-NX) is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K170681. 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 Continuous Single Culture -NX (CSCM-NX)?

Continuous Single Culture -NX (CSCM-NX) is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Irvine Scientific Sales Co., Inc.. The 510(k) number is K170681.

When did Continuous Single Culture -NX (CSCM-NX) receive FDA 510(k) clearance?

Continuous Single Culture -NX (CSCM-NX) received FDA 510(k) clearance on 2017-06-08, under 510(k) number K170681.

Who is the listed applicant for Continuous Single Culture -NX (CSCM-NX)?

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

What is the FDA product code for Continuous Single Culture -NX (CSCM-NX)?

The FDA product code for Continuous Single Culture -NX (CSCM-NX) is MQL.

Other records listing Irvine Scientific Sales Co., Inc. 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.

K171224Arctic Sperm Cryopreservation Medium K170602Continuous Single Culture-NX Complete (CSCM-NXC)

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.