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FDA 510(k)

RAPIDVIT AND RAPIDWARM CLEAVE

K-Number: K080446 · 2008-11-26

ApplicantVitrolife Sweden AB
Decision Date2008-11-26
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

RAPIDVIT AND RAPIDWARM CLEAVE is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2008-11-26 under 510(k) number K080446. 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 RAPIDVIT AND RAPIDWARM CLEAVE?

RAPIDVIT AND RAPIDWARM CLEAVE is a medical device that received FDA 510(k) clearance on 2008-11-26. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K080446.

When did RAPIDVIT AND RAPIDWARM CLEAVE receive FDA 510(k) clearance?

RAPIDVIT AND RAPIDWARM CLEAVE received FDA 510(k) clearance on 2008-11-26, under 510(k) number K080446.

Who is the listed applicant for RAPIDVIT AND RAPIDWARM CLEAVE?

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

What is the FDA product code for RAPIDVIT AND RAPIDWARM CLEAVE?

The FDA product code for RAPIDVIT AND RAPIDWARM CLEAVE is MQL.

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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

View on FDA Database →

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

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