VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium— 510(k) K212410
Substantially EquivalentShenzhen Vitavitro Biotech Co., Ltd.
FDA 510(k) clearance K212410 for VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium, Substantially Equivalent on 2022-02-01. Applicant: Shenzhen Vitavitro Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Vitavitro Biotech Co., Ltd.
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code MQL
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- K200408 — VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
- K191063 — 1-Step Culture Medium
Data sourced from openFDA. This site is unofficial and independent of the FDA.