1-Step Culture Medium
FDA 510(k) clearance K191063 · decided 2019-08-23
Clearance details
- K-number
- K191063
- Device name
- 1-Step Culture Medium
- Applicant
- Shenzhen Vitavitro Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-04-22
- Decision date
- 2019-08-23
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.