The following data is part of a premarket notification filed by Shenzhen Vitavitro Biotech Co.,ltd. with the FDA for Vitavitro Sperm Washing Medium, Vitavitro Sperm Gradient Medium.
| Device ID | K212410 |
| 510k Number | K212410 |
| Device Name: | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient 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 | 2021-08-03 |
| Decision Date | 2022-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971982050199 | K212410 | 000 |
| 16971982050011 | K212410 | 000 |
| 16971982050035 | K212410 | 000 |
| 06971982050113 | K212410 | 000 |
| 06971982050120 | K212410 | 000 |
| 06971982050137 | K212410 | 000 |
| 06971982050144 | K212410 | 000 |
| 06971982050151 | K212410 | 000 |
| 06971982050168 | K212410 | 000 |
| 06971982050175 | K212410 | 000 |
| 06971982050182 | K212410 | 000 |
| 16971982050004 | K212410 | 000 |