SPERMCARE Upper Layer - Gradient System 2221-50
SPERMCARE Upper Layer - Gradient System 2221-50 is an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by Invitrocare Inc, cleared under FDA 510(k) K053494 on 23 Mar 2006 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00859268006183), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00859268006183 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK053494 | Date23 Mar 2006 | StatusActive |
Official records
- AccessGUDID record 00859268006183
- FDA 510(k) database K053494
Across registries
- FDA 510(k) K053494 decided 23 Mar 2006 Active
- FDA GUDID UDI-DI 00859268006183 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K053494
- Listed FDA GUDID 00859268006183
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SPERMCARE Upper Layer - Gradient System
- Generic name
- IVF medium
- Model / Ref / Catalog
- 2221-50
- Primary DI / UDI-DI
- 00859268006183
- 510(k) Number
- FDA product code
- MQL
- GMDN term
- IVF medium
- Device class
- Class II
- Regulation number
- 884.6180
- GUDID distribution status
- In Commercial Distribution
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