VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium— 510(k) K200408
Substantially EquivalentShenzhen Vitavitro Biotech Co., Ltd.
FDA 510(k) clearance K200408 for VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium, Substantially Equivalent on 2020-10-16. 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
view allMore clearances from Shenzhen Vitavitro Biotech Co., Ltd.
view all- K240523 — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
- K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
- K212410 — VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
- K191063 — 1-Step Culture Medium
Data sourced from openFDA. This site is unofficial and independent of the FDA.