The following data is part of a premarket notification filed by Shenzhen Vitavitro Biotech Co., Ltd. with the FDA for 1-step Culture Medium.
| Device ID | K191063 |
| 510k Number | K191063 |
| Device Name: | 1-Step Culture 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 | Xiaozhen Lin 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 | 2019-04-22 |
| Decision Date | 2019-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971982050052 | K191063 | 000 |
| 06971982050045 | K191063 | 000 |
| 06971982050038 | K191063 | 000 |