510(k) K161261
K161261 is an FDA 510(k) premarket notification submitted by Genea Biomedx Pty, Ltd. for the device "Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase". The FDA issued a decision of Substantially Equivalent on May 12, 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 12, 2017
- Date Received
- May 4, 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