KSO · Centrifuge, Blood-Bank For In Vitro Diagnostic Use
Hematology · 21 CFR 864.9275 · Class 1
Overview
| Product Code | KSO |
|---|---|
| Device Name | Centrifuge, Blood-Bank For In Vitro Diagnostic Use |
| Regulation | 21 CFR 864.9275 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K780281 | IMMUFUGE DISP. LINER | Dade, Baxter Travenol Diagnostics, Inc. | Mar 2, 1978 | SESE |
Top Applicants
- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance
