ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)— 510(k) K173075
Substantially EquivalentDxnow, Inc.
FDA 510(k) clearance K173075 for ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml), Substantially Equivalent on 2018-03-08. Applicant: Dxnow, Inc.. Device class: 2.
Clearance details
- Applicant
- Dxnow, Inc.
- Product code
- Code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Gaithersburg, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.