510(k) K161261
- Device
- Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase
- Applicant
- Genea Biomedx Pty Ltd
- 510(k) number
- K161261
- Product code
- MQL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-12
- Date received
- 2016-05-04
- Regulation
- 884.6180
- Classification name
- Media, Reproductive
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Kea Dent
- Address
- Level 2, 321 Kent St. Sydney AU 2000 2000
FDA Registration Numbers
- 3007800906
- 3004048494
- 3030681110
- 1221433
- 2022379
- 3025773437
- 3014755376
- 3003995932
- 3014295858
- 3021166069
- 3036725842
- 3003766921
- 3008876063
- 2031824
- 3005580113
- 3004882774
- 3003272500
- 3016126174
- 1216677
- 3007738736
- 3017896194
- 3018010054
- 3010413864
- 3033813683
- 3030390242
- 1222779
- 9616005
- 3003274090
- 3012853704
- 3015140190
- 3036495174
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
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