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FDA 510(k)

VITRIFREEZE MEDIUM; VITRITHAW MEDIUM

K-Number: K070135 · 2007-08-16

ApplicantFertipro NV
Decision Date2007-08-16
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VITRIFREEZE MEDIUM; VITRITHAW MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Fertipro NV. It received FDA 510(k) clearance on 2007-08-16 under 510(k) number K070135. 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 VITRIFREEZE MEDIUM; VITRITHAW MEDIUM?

VITRIFREEZE MEDIUM; VITRITHAW MEDIUM is a medical device that received FDA 510(k) clearance on 2007-08-16. The listed applicant is Fertipro NV. The 510(k) number is K070135.

When did VITRIFREEZE MEDIUM; VITRITHAW MEDIUM receive FDA 510(k) clearance?

VITRIFREEZE MEDIUM; VITRITHAW MEDIUM received FDA 510(k) clearance on 2007-08-16, under 510(k) number K070135.

Who is the listed applicant for VITRIFREEZE MEDIUM; VITRITHAW MEDIUM?

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

What is the FDA product code for VITRIFREEZE MEDIUM; VITRITHAW MEDIUM?

The FDA product code for VITRIFREEZE MEDIUM; VITRITHAW MEDIUM is MQL.

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Other records listing Fertipro NV as applicant

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K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinK221547InActiv BlueK053494OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE

Related Devices (Code: MQL)

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.

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin 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

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.

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