The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Vit Kit-freeze Oocytes, Embryos And Pn Zygotes Vitrification Freeze Kit, Vit Kit-thaw Oocytes, Embryos And Pn Zygotes Vitrification Thaw Kit.
| Device ID | K160006 |
| 510k Number | K160006 |
| Device Name: | Vit Kit-Freeze Oocytes, Embryos And PN Zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos And PN Zygotes Vitrification Thaw Kit |
| Classification | Media, Reproductive |
| Applicant | Irvine Scientific 2511 Daimler St Santa Ana, CA 92705 |
| Contact | Jayme Yamaguchi-owens |
| Correspondent | Jayme Yamaguchi-owens Irvine Scientific 2511 Daimler St Santa Ana, CA 92705 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-04 |
| Decision Date | 2016-05-04 |
| Summary: | summary |