Bio-Rad, Diagnostics Grp. · Class II · Cleared Jun 26, 2007
| K-number | K071319 |
| Device name | I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 |
| Applicant | Bio-Rad, Diagnostics Grp. |
| Product code | GGN |
| Device class | Class II |
| Decision date | Jun 26, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 864.5425 |
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