AMYLASE — Pointe Scientific, Inc., (510(k) K832889)
AMYLASE — Pointe Scientific, Inc., (510(k) K832889) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: AMYLASE; Applicant: Pointe Scientific, Inc.,; Clearance track: 510(k).
| Device name | AMYLASE |
|---|---|
| Applicant | Pointe Scientific, Inc., |
| Clearance track | 510(k) |
| Submission number | K832889 |
| Decision | Substantially Equivalent |
| Decision date | 1983-11-25 |
| Date received | 1983-08-22 |
| Product code | JFJ |
| Device class | 2 |
| Medical specialty | Clinical Chemistry |
| Applicant location | IL, US |
| Source | openFDA device |
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