SCANDINAVIAN IVF SCIENCES AB, GAMETE-100— 510(k) K000626

Name: FDA 510(k) clearance K000626
Creator: U.S. Food and Drug Administration
Published: 2000-05-23

Substantially Equivalent

Vitrolife AB/Scandinavian Ivf Sciences AB

FDA 510(k) clearance K000626 for SCANDINAVIAN IVF SCIENCES AB, GAMETE-100, Substantially Equivalent on 2000-05-23. Applicant: Vitrolife AB/Scandinavian Ivf Sciences AB. Device class: 2.

Clearance details

Applicant: Vitrolife AB/Scandinavian Ivf Sciences AB
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2000-02-17
Decision date: 2000-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vitrolife AB/Scandinavian Ivf Sciences AB

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K000619 — SCANDINAVIAN IVF SCIENCES AB, G2.22000-06-27
K000627 — SCANDINAVIAN IVF SCIENCES AB, HYBASE-12000-06-13
K000625 — SCANDINAVIAN IVF SCIENCES AB, G1.22000-05-23
K000618 — SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 12000-05-17
K000621 — SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/1002000-05-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.