Stat Profile Phox Ultra/Ccx
by Nova Biomedical Corporation 17 variants
Stat Profile Phox Ultra/Ccx (48591) is a Class I device made by Nova Biomedical Corporation, cleared under FDA 510(k) K110648 on 29 Aug 2011 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480485913), 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 | Number00385480485913 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110648 | Date29 Aug 2011 | StatusActive |
Official records
- AccessGUDID record 00385480485913
- FDA 510(k) database K110648
Across registries
- FDA 510(k) K110648 decided 29 Aug 2011 Active
- FDA GUDID UDI-DI 00385480485913 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K110648
- Listed FDA GUDID 00385480485913
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stat Profile
- Generic name
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
- Model / Ref / Catalog
- PHOX ULTRA/CCX, 48591
- Primary DI / UDI-DI
- 00385480485913
- 510(k) Number
- FDA product code
- JKS
- GMDN term
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
- Device class
- Class I
- Regulation number
- 862.3220
- GUDID distribution status
- In Commercial Distribution
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