i-STAT 06P17-13
i-STAT 06P17-13 is a Class II device made by Abbott Point of Care Inc., cleared under FDA 510(k) K120900 on 31 May 2013 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00054749001217), 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 | Number00054749001217 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120900 | Date31 May 2013 | StatusActive |
Official records
- AccessGUDID record 00054749001217
- FDA 510(k) database K120900
Across registries
- FDA 510(k) K120900 decided 31 May 2013 Active
- FDA GUDID UDI-DI 00054749001217 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K120900
- Listed FDA GUDID 00054749001217
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- i-STAT
- Generic name
- Prothrombin time (PT) IVD, control
- Model / Ref / Catalog
- 06P17-13
- Primary DI / UDI-DI
- 00054749001217
- 510(k) Number
- FDA product code
- GGN
- GMDN term
- Prothrombin time (PT) IVD, control
- Device class
- Class II
- Regulation number
- 864.5425
- GUDID distribution status
- In Commercial Distribution
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