| K-number | K921477 |
| Device name | I-STAT(TM) LEVELS 1,2,3 CONTROLS |
| Applicant | I-Stat Corp. |
| Product code | JJY |
| Device class | Class I |
| Decision date | Nov 2, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
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