Centrifuge, Blood-Bank For In Vitro Diagnostic Use
This device is a blood bank centrifuge for in vitro diagnostic use, used to separate blood components such as red cells, plasma, and platelets, and to process serological test samples in blood bank and transfusion medicine laboratories. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is KSO, regulated under 21 CFR 864.9275 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSO
- Device Class
- FDA class 1
- Regulation Number
- 864.9275
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K780281 | IMMUFUGE DISP. LINER | Mar 02, 1978 | Substantially Equivalent | Dade, Baxter Travenol Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.