Savanna 20382R
Savanna 20382R is a Class II device made by Diagnostic Hybrids, Inc., cleared under FDA 510(k) K232286 on 20 Dec 2023 and listed in FDA GUDID since 19 Jul 2024 (UDI-DI 30014613340089), 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 | Number30014613340089 | Date19 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232286 | Date20 Dec 2023 | StatusActive |
Official records
- AccessGUDID record 30014613340089
- FDA 510(k) database K232286
Across registries
- FDA 510(k) K232286 decided 20 Dec 2023 Active
- FDA GUDID UDI-DI 30014613340089 listed 19 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K232286
- Listed FDA GUDID 30014613340089
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Savanna
- Generic name
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care
- Model / Ref / Catalog
- 20382R
- Primary DI / UDI-DI
- 30014613340089
- 510(k) Number
- FDA product code
- OOI
- GMDN term
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care
- Device class
- Class II
- Regulation number
- 862.2570
- GUDID distribution status
- In Commercial Distribution
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