Stat Profile 1
by Nova Biomedical Corporation 3 variants
Stat Profile 1 (11802) 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 22 Sep 2016 (UDI-DI 00385480118026), 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 | Number00385480118026 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK014295 | Date28 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 00385480118026
- FDA 510(k) database K014295
Across registries
- FDA 510(k) K014295 decided 28 Feb 2002 Active
- FDA GUDID UDI-DI 00385480118026 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K014295
- Listed FDA GUDID 00385480118026
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- Withdrawn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
- 1, 11802
- Primary DI / UDI-DI
- 00385480118026
- 510(k) Number
- FDA product code
- JIX, CDS, CHL, CGZ, JGS, JFP, JKS, JPI, KHP, JJY, CFA, CEM
- GMDN term
- Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
- Device class
- Class II
- Regulation number
- 862.1150, 862.1770, 862.1120, 862.1170, 862.1665, 862.1145, 862.3220, 864.6400, 862.1450, 862.1660, 862.1495, 862.1600
- GUDID distribution status
- In Commercial Distribution
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