Gems Oocyte Retrieval Buffer ORB-20, ORB-50— 510(k) K170498

Name: FDA 510(k) clearance K170498
Creator: U.S. Food and Drug Administration
Published: 2017-09-28

Substantially Equivalent

Genea Biomedx Pty, Ltd.

FDA 510(k) clearance K170498 for Gems Oocyte Retrieval Buffer ORB-20, ORB-50, Substantially Equivalent on 2017-09-28. Applicant: Genea Biomedx Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Genea Biomedx Pty, Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2017-02-17
Decision date: 2017-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

Download summary PDF View on FDA.gov ↗

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