KSN · Centrifuge, Cell-Washing, Automated For Immuno-Hematology
Hematology · 21 CFR 864.9285 · Class 2
Overview
| Product Code | KSN |
|---|---|
| Device Name | Centrifuge, Cell-Washing, Automated For Immuno-Hematology |
| Regulation | 21 CFR 864.9285 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K790767 | IMMU-TEK AUTOMATIC CENTRIFUGE | Dade, Baxter Travenol Diagnostics, Inc. | May 23, 1979 | SESE |
Top Applicants
- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance
