Submission Details
| 510(k) Number | K191063 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 22, 2019 |
| Decision Date | August 23, 2019 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
1-Step Culture Medium
Aug 2019
Decision
123d
Days
Class 2
Risk
About This 510(k) Submission
K191063 is an FDA 510(k) clearance for the 1-Step Culture Medium, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Shenzhen Vitavitro Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 23, 2019, 123 days after receiving the submission on April 22, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
Device Classification
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6180 |
Manufacturer
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