NOVA Lite® Thyroid 708350
NOVA Lite® Thyroid 708350 is a Class II device made by Inova Diagnostics. Inc., cleared under FDA 510(k) K904224 on 15 Oct 1990 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 08426950596240), active as of 8 Nov 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 | Number08426950596240 | Date31 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK904224 | Date15 Oct 1990 | StatusActive |
Official records
- AccessGUDID record 08426950596240
- FDA 510(k) database K904224
Across registries
- FDA 510(k) K904224 decided 15 Oct 1990 Active
- FDA GUDID UDI-DI 08426950596240 listed 31 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K904224
- Listed FDA GUDID 08426950596240
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NOVA Lite® Thyroid
- Generic name
- Multiple thyroid antibody IVD, kit, fluorescent immunoassay
- Model / reference
- 708350
- Primary DI / UDI-DI
- 08426950596240
- 510(k) Number
- FDA product code
- JZO
- GMDN term
- Multiple thyroid antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.5870
- GUDID distribution status
- In Commercial Distribution
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