HEMA SCREEN ER — Immunostics Inc., (510(k) K102664)
HEMA SCREEN ER — Immunostics Inc., (510(k) K102664) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: HEMA SCREEN ER; Applicant: Immunostics Inc.,; Clearance track: 510(k).
| Device name | HEMA SCREEN ER |
|---|---|
| Applicant | Immunostics Inc., |
| Clearance track | 510(k) |
| Submission number | K102664 |
| Decision | Substantially Equivalent |
| Decision date | 2011-01-28 |
| Date received | 2010-09-15 |
| Product code | KHE |
| Device class | 2 |
| Medical specialty | Hematology |
| Applicant location | NJ, US |
| Source | openFDA device |
🔍 Search all device clearances →
$1999/mo
Try DeviceClear →