VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
Media, Reproductive
Shenzhen VitaVitro Biotech Co.,Ltd.
The following data is part of a premarket notification filed by Shenzhen Vitavitro Biotech Co.,ltd. with the FDA for Vitavitro® Fertilization Medium, Vitavitro® Gamete Buffer Medium, Vitavitro® Flushing Buffer Medium.
Pre-market Notification Details
| Device ID | K200408 |
| 510k Number | K200408 |
| Device Name: | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium |
| Classification | Media, Reproductive |
| Applicant | Shenzhen VitaVitro Biotech Co.,Ltd. R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No. 16 Shenzhen, CN 518118 |
| Contact | Donghai Pan |
| Correspondent | Donghai Pan Shenzhen VitaVitro Biotech Co., Ltd. R601, Building B, Hai Ke Xing Tech Park, Baoshan Road No. 16 Shenzhen, CN 518118 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-19 |
| Decision Date | 2020-10-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971982050106 | K200408 | 000 |
| 06971982050090 | K200408 | 000 |
| 06971982050083 | K200408 | 000 |
| 06971982050076 | K200408 | 000 |
| 06971982050069 | K200408 | 000 |
Trademark Results [VitaVitro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITAVITRO 79251809 not registered Live/Pending |
Shenzhen VitaVitro Biotech Co., Ltd. 2018-07-26 |
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