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FDA 510(k)

VITRIFICATION KIT & VITRIFICATION WARMING KIT

K-Number: K073522 · 2008-10-10

ApplicantSage In-Vitro Fertilization, Inc.
Decision Date2008-10-10
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VITRIFICATION KIT & VITRIFICATION WARMING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Sage In-Vitro Fertilization, Inc.. It received FDA 510(k) clearance on 2008-10-10 under 510(k) number K073522. 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 VITRIFICATION KIT & VITRIFICATION WARMING KIT?

VITRIFICATION KIT & VITRIFICATION WARMING KIT is a medical device that received FDA 510(k) clearance on 2008-10-10. The listed applicant is Sage In-Vitro Fertilization, Inc.. The 510(k) number is K073522.

When did VITRIFICATION KIT & VITRIFICATION WARMING KIT receive FDA 510(k) clearance?

VITRIFICATION KIT & VITRIFICATION WARMING KIT received FDA 510(k) clearance on 2008-10-10, under 510(k) number K073522.

Who is the listed applicant for VITRIFICATION KIT & VITRIFICATION WARMING KIT?

The FDA 510(k) record lists Sage In-Vitro Fertilization, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITRIFICATION KIT & VITRIFICATION WARMING KIT?

The FDA product code for VITRIFICATION KIT & VITRIFICATION WARMING KIT is MQL.

Related Clinical Trials

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.

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Other records listing Sage In-Vitro Fertilization, 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.

K053646INVITRO MATURATION MEDIA

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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