IMMU-TEK AUTOMATIC CENTRIFUGE
Device Facts
| Record ID | K790767 |
|---|---|
| Device Name | IMMU-TEK AUTOMATIC CENTRIFUGE |
| Applicant | Dade, Baxter Travenol Diagnostics, Inc. |
| Product Code | KSN · Hematology |
| Decision Date | May 23, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9285 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing.
