Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA

K-Number: K053552 · 2006-05-19

Applicant<Genx> Intl., Inc.
Decision Date2006-05-19
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER 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 2006-05-19 under 510(k) number K053552. 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 FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA?

GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA is a medical device that received FDA 510(k) clearance on 2006-05-19. The listed applicant is <Genx> Intl., Inc.. The 510(k) number is K053552.

When did GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA receive FDA 510(k) clearance?

GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA received FDA 510(k) clearance on 2006-05-19, under 510(k) number K053552.

Who is the listed applicant for GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER 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 FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA?

The FDA product code for GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA is MQL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 32 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.

↑