The following data is part of a premarket notification filed by Fujifilm Irvine Scientific, Inc. with the FDA for Vit Kit- Freeze Nx And Vit Kit- Warm Nx.
| Device ID | K190152 |
| 510k Number | K190152 |
| Device Name: | Vit Kit- Freeze NX And Vit Kit- Warm NX |
| Classification | Media, Reproductive |
| Applicant | FUJIFILM Irvine Scientific, Inc. 2511 Daimler Street Santa Ana, CA 92705 |
| Contact | Jayme Yamaguchi-owens |
| Correspondent | Jayme Yamaguchi-owens FUJIFILM Irine Scientific, Inc. 2511 Daimler Street 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 | 2019-01-30 |
| Decision Date | 2019-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857515006320 | K190152 | 000 |
| 00857515006313 | K190152 | 000 |
| 00857515006627 | K190152 | 000 |