Thermo Scientific Forma 3121
by Thermo Fisher Scientific (Asheville) LLC
Thermo Scientific Forma 3121 is a Class II device made by Thermo Fisher Scientific (Asheville) LLC, cleared under FDA 510(k) K991408 on 19 Jul 1999 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 10815773020110), active as of 23 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 | Number10815773020110 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK991408 | Date19 Jul 1999 | StatusActive |
Official records
- AccessGUDID record 10815773020110
- FDA 510(k) database K991408
Across registries
- FDA 510(k) K991408 decided 19 Jul 1999 Active
- FDA GUDID UDI-DI 10815773020110 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K991408
- Listed FDA GUDID 10815773020110
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Thermo Scientific Forma
- Generic name
- Assisted reproduction heater/incubator
- Model / Ref / Catalog
- 3121
- Primary DI / UDI-DI
- 10815773020110
- 510(k) Number
- FDA product code
- MQG
- GMDN term
- Assisted reproduction heater/incubator
- Device class
- Class II
- Regulation number
- 884.6120
- GUDID distribution status
- In Commercial Distribution
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