Embryogen
510(k) K120136
Embryogen is a medical device (FDA Class II; FDA product code MQL, Media, Reproductive) made by Origio A/S, cleared under FDA 510(k) K120136 on 26 Sep 2012, active as of 9 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120136 | Date26 Sep 2012 | StatusActive |
Official records
- FDA 510(k) database K120136
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQL
- Device class
- Class II
- Regulation
- 21 CFR Part 884.6180
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
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