KSO — Centrifuge, Blood-Bank For In Vitro Diagnostic Use Class I
FDA product code KSO covers "Centrifuge, Blood-Bank For In Vitro Diagnostic Use", a Class I medical device regulated under 21 CFR 864.9275. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- KSO
- Device Class
- Class I
- Regulation Number
- 864.9275
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K780281 | dade, baxter travenol diagnostics | IMMUFUGE DISP. LINER | March 2, 1978 |