KARYOTEC 100
Device Facts
| Record ID | K872755 |
|---|---|
| Device Name | KARYOTEC 100 |
| Applicant | Amcor Electronics, Ltd. |
| Product Code | LNJ · Hematology |
| Decision Date | Sep 1, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5260 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)
