The following data is part of a premarket notification filed by Dxnow, Inc. with the FDA for Zymot Icsi Sperm Separation Device, Zymot Multi Sperm Separation Device (850µl, 3ml).
| Device ID | K173075 |
| 510k Number | K173075 |
| Device Name: | ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) |
| Classification | Labware, Assisted Reproduction |
| Applicant | DxNow, Inc. 401 Professional Drive, Suite 130 Gaithersburg, MD 20879 -3429 |
| Contact | William T. Sharp |
| Correspondent | Kevin Sly DxNOW, INC 401 Professional Drive, Suite 130 Gaithersburg, MD 20879 -3429 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860451001250 | K173075 | 000 |
| 00860451001243 | K173075 | 000 |
| 00860451001236 | K173075 | 000 |
| 00860004123903 | K173075 | 000 |
| 00860004123941 | K173075 | 000 |
| 00860004123934 | K173075 | 000 |