STAT PROFILE pHOx/BASIC
by Nova Biomedical Corporation 4 variants
STAT PROFILE pHOx/BASIC (21513) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K014295 on 28 Feb 2002 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480215138), 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 | Number00385480215138 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK014295 | Date28 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 00385480215138
- FDA 510(k) database K014295
Across registries
- FDA 510(k) K014295 decided 28 Feb 2002 Active
- FDA GUDID UDI-DI 00385480215138 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K014295
- Listed FDA GUDID 00385480215138
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stat Profile
- Generic name
- Blood gas/haemoximetry analyser IVD, point-of-care
- Model / Ref / Catalog
- pHOx/BASIC, 21513
- Primary DI / UDI-DI
- 00385480215138
- 510(k) Number
- FDA product code
- JPK, JIX, CHL, GKR, JKS, JPI
- GMDN term
- Blood gas/haemoximetry analyser IVD, point-of-care
- Device class
- Class II
- Regulation number
- 864.8625, 862.1150, 862.1120, 864.5620, 862.3220, 864.6400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Blood gas/haemoximetry analyser IVD, point-of-care.