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FDA 510(k)

SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

K-Number: K000623 · 2000-05-16

ApplicantVitrolife AB/Scandinavian Ivf Sciences AB
Decision Date2000-05-16
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife AB/Scandinavian Ivf Sciences AB. It received FDA 510(k) clearance on 2000-05-16 under 510(k) number K000623. 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 SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1?

SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 is a medical device that received FDA 510(k) clearance on 2000-05-16. The listed applicant is Vitrolife AB/Scandinavian Ivf Sciences AB. The 510(k) number is K000623.

When did SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 receive FDA 510(k) clearance?

SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 received FDA 510(k) clearance on 2000-05-16, under 510(k) number K000623.

Who is the listed applicant for SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1?

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

What is the FDA product code for SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1?

The FDA product code for SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1 is MQL.

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Other records listing Vitrolife AB/Scandinavian Ivf Sciences AB 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.

K000619SCANDINAVIAN IVF SCIENCES AB, G2.2K000627SCANDINAVIAN IVF SCIENCES AB, HYBASE-1K000626SCANDINAVIAN IVF SCIENCES AB, GAMETE-100K000625SCANDINAVIAN IVF SCIENCES AB, G1.2K000618SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1K000621SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100

View all 7 devices →

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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