G-Freezekit Blast

FDA 510(k) K032154 · Vitrolife AB

Substantially Equivalent

510(k) numberK032154

Submission

Device name
G-Freezekit Blast
Applicant
Vitrolife AB
Washington, DC, US
Received
July 14, 2003
Decision date
May 7, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQL – Media, Reproductive
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6180
Specialty
Obstetrics/Gynecology

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K260248Ultra-Fast WarmMQL · Traditional Kitazato Corporation04/28/2026SE
K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)MQL · Traditional Casebioscience, Inc.02/20/2026SE
K250445Fast Warm - NXMQL · Traditional Fujifilm Irvine Scientific09/12/2025SE
K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…MQL · Traditional Donnevie Medical Technology (Shanghai) Co. , Ltd.08/27/2025SE
K251305Ultra-Fast Vitri; Ultra-Fast WarmMQL · Traditional Kitazato Corporation08/26/2025SE
K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinMQL · Traditional Fertipro NV05/30/2025SE
K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)MQL · Traditional Donnevie Medical Technology (Shanghai) Co. , Ltd.04/10/2025SE
K242089Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)MQL · Traditional Jiangsu Ruifuda Medical Device Co., Ltd.04/10/2025SE
K242107CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC)…MQL · Traditional Casebioscience, Inc.03/21/2025SE

More from Casebioscience, Inc.

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K032155G-Thawkit BlastMQL · Traditional 05/07/2004SE
K022730Perfadex Solution for Lung PreservationMSB · Traditional 10/27/2003SE

Questions and answers

When was G-Freezekit Blast cleared by the FDA?

G-Freezekit Blast (K032154) received a 510(k) decision of Substantially Equivalent on May 7, 2004, 298 days after the submission was received.

What is the product code of K032154?

The FDA product code is MQL – Media, Reproductive, a Class II (moderate risk) device regulated under 21 CFR 884.6180.