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FDA 510(k)

GLOBAL BY <GENX> BLASTOCYST MEDIA

K-Number: K010183 · 2001-05-02

Applicant<Genx> Intl., Inc.
Decision Date2001-05-02
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GLOBAL BY <GENX> BLASTOCYST MEDIA is the device name listed in this FDA 510(k) record. The listed applicant is <Genx> Intl., Inc.. It received FDA 510(k) clearance on 2001-05-02 under 510(k) number K010183. 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 GLOBAL BY <GENX> BLASTOCYST MEDIA?

GLOBAL BY <GENX> BLASTOCYST MEDIA is a medical device that received FDA 510(k) clearance on 2001-05-02. The listed applicant is <Genx> Intl., Inc.. The 510(k) number is K010183.

When did GLOBAL BY <GENX> BLASTOCYST MEDIA receive FDA 510(k) clearance?

GLOBAL BY <GENX> BLASTOCYST MEDIA received FDA 510(k) clearance on 2001-05-02, under 510(k) number K010183.

Who is the listed applicant for GLOBAL BY <GENX> BLASTOCYST MEDIA?

The FDA 510(k) record lists <Genx> Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOBAL BY <GENX> BLASTOCYST MEDIA?

The FDA product code for GLOBAL BY <GENX> BLASTOCYST MEDIA is MQL.

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Other records listing <Genx> Intl., 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.

K112083LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPESK092963GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3K092667GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KITK092578LIFEGLOBAL PROTEIN SUPPLEMENTK083509LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSAK080395SUNIVF DISHES

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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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