I-Stat Corporation · Class II · Cleared Jan 13, 2006
| K-number | K053110 |
| Device name | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge |
| Applicant | I-Stat Corporation |
| Product code | JGS |
| Device class | Class II |
| Decision date | Jan 13, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 862.1665 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov