Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])— 510(k) K212426
Substantially EquivalentDonnevie Medical Technology (Shanghai) Co. , Ltd.
FDA 510(k) clearance K212426 for Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]), Substantially Equivalent on 2022-06-16. Applicant: Donnevie Medical Technology (Shanghai) Co. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Donnevie Medical Technology (Shanghai) 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
- Shanghai, CN
Recent devices under product code MQL
view allMore clearances from Donnevie Medical Technology (Shanghai) Co. , Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.