Nova 10
by Nova Biomedical Corporation 11 variants
Nova 10 (13198) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K923806 on 29 Sep 1992 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00385480131988), 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 | Number00385480131988 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK923806 | Date29 Sep 1992 | StatusActive |
Official records
- AccessGUDID record 00385480131988
- FDA 510(k) database K923806
Across registries
- FDA 510(k) K923806 decided 29 Sep 1992 Active
- FDA GUDID UDI-DI 00385480131988 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K923806
- Listed FDA GUDID 00385480131988
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nova
- Generic name
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
- Model / Ref / Catalog
- 10, 13198
- Primary DI / UDI-DI
- 00385480131988
- 510(k) Number
- FDA product code
- NDW, CGZ, JGS, JFP, CEM
- GMDN term
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
- Device class
- Class II
- Regulation number
- 862.3560, 862.1170, 862.1665, 862.1145, 862.1600
- GUDID distribution status
- In Commercial Distribution
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