Nova 11
by Nova Biomedical Corporation
Nova 11 (15649) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K915178 on 27 Jan 1992 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480156493), 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 | Number00385480156493 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK915178 | Date27 Jan 1992 | StatusActive |
Official records
- AccessGUDID record 00385480156493
- FDA 510(k) database K915178
Across registries
- FDA 510(k) K915178 decided 27 Jan 1992 Active
- FDA GUDID UDI-DI 00385480156493 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K915178
- Listed FDA GUDID 00385480156493
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nova
- Generic name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
- Model / Ref / Catalog
- 11, 15649
- Primary DI / UDI-DI
- 00385480156493
- 510(k) Number
- FDA product code
- JIX
- GMDN term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
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