510(k) K162409
K162409 is an FDA 510(k) premarket notification submitted by Genea Biomedx Pty, Ltd. for the device "Gems Vitrification Set, Gems Warming Set". The FDA issued a decision of Substantially Equivalent on May 24, 2017. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Genea Biomedx Pty, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2017
- Date Received
- August 29, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type