The following data is part of a premarket notification filed by Genea Biomedx Pty Ltd with the FDA for Gems Oocyte Retrieval Buffer Orb-20, Orb-50.
| Device ID | K170498 |
| 510k Number | K170498 |
| Device Name: | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 |
| Classification | Media, Reproductive |
| Applicant | Genea Biomedx Pty Ltd Level 2, 321 Kent Street Sydney, AU 2000 |
| Contact | Kea Dent |
| Correspondent | Roger Gray Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, IT 00153 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-17 |
| Decision Date | 2017-09-28 |
| Summary: | summary |