The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Continuous Single Culture-nx Complete (cscm-nxc).
| Device ID | K170602 |
| 510k Number | K170602 |
| Device Name: | Continuous Single Culture-NX Complete (CSCM-NXC) |
| Classification | Media, Reproductive |
| Applicant | Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705 |
| Contact | Jayme Yamaguchi-owens |
| Correspondent | Jayme Yamaguchi-owens Irvine Scientific Sales Co., 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 | 2017-03-01 |
| Decision Date | 2017-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857515006238 | K170602 | 000 |
| 00857515006429 | K170602 | 000 |