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)

SCANDINAVIAN IVF SCIENCES AB, HYBASE-1

K-Number: K000627 · 2000-06-13

ApplicantVitrolife AB/Scandinavian Ivf Sciences AB
Decision Date2000-06-13
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SCANDINAVIAN IVF SCIENCES AB, HYBASE-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 2000-06-13 under 510(k) number K000627. 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, HYBASE-1?

SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 is a medical device that received FDA 510(k) clearance on 2000-06-13. The listed applicant is Vitrolife AB/Scandinavian Ivf Sciences AB. The 510(k) number is K000627.

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

SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 received FDA 510(k) clearance on 2000-06-13, under 510(k) number K000627.

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

The FDA product code for SCANDINAVIAN IVF SCIENCES AB, HYBASE-1 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 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, G2.2K000626SCANDINAVIAN IVF SCIENCES AB, GAMETE-100K000625SCANDINAVIAN IVF SCIENCES AB, G1.2K000618SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1K000621SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100K000623SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

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.

↑