I-STAT SYSTEM — I-Stat Corp. (510(k) K973292)
I-STAT SYSTEM — I-Stat Corp. (510(k) K973292) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: I-STAT SYSTEM; Applicant: I-Stat Corp.; Clearance track: 510(k).
| Device name | I-STAT SYSTEM |
|---|---|
| Applicant | I-Stat Corp. |
| Clearance track | 510(k) |
| Submission number | K973292 |
| Decision | Substantially Equivalent |
| Decision date | 1997-10-20 |
| Date received | 1997-09-02 |
| Product code | CGL |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | NJ, US |
| Source | openFDA device |
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$1999/mo
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