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FDA 510(k)

INVITRO MATURATION MEDIA

K-Number: K053646 · 2006-07-14

ApplicantSage In-Vitro Fertilization, Inc.
Decision Date2006-07-14
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INVITRO MATURATION MEDIA 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 2006-07-14 under 510(k) number K053646. 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 INVITRO MATURATION MEDIA?

INVITRO MATURATION MEDIA is a medical device that received FDA 510(k) clearance on 2006-07-14. The listed applicant is Sage In-Vitro Fertilization, Inc.. The 510(k) number is K053646.

When did INVITRO MATURATION MEDIA receive FDA 510(k) clearance?

INVITRO MATURATION MEDIA received FDA 510(k) clearance on 2006-07-14, under 510(k) number K053646.

Who is the listed applicant for INVITRO MATURATION MEDIA?

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 INVITRO MATURATION MEDIA?

The FDA product code for INVITRO MATURATION MEDIA is MQL.

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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.

K073522VITRIFICATION KIT & VITRIFICATION WARMING KIT

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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