The following data is part of a premarket notification filed by Vitrolife Ab/scandinavian Ivf Sciences Ab with the FDA for Scandinavian Ivf Sciences Ab, Gamete-100.
| Device ID | K000626 |
| 510k Number | K000626 |
| Device Name: | SCANDINAVIAN IVF SCIENCES AB, GAMETE-100 |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Contact | Gary L Yingling |
| Correspondent | Gary L Yingling VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-17 |
| Decision Date | 2000-05-23 |