KSQ — Device, Blood Mixing And Blood Weighing Class I
FDA product code KSQ covers "Device, Blood Mixing And Blood Weighing", a Class I medical device regulated under 21 CFR 864.9195. Submissions are reviewed by the Hematology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KSQ
- Device Class
- Class I
- Regulation Number
- 864.9195
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K842746 | r and d systems | HYCEL ROTOR-MIXER AND/OR MULTI | August 17, 1984 |
| K820712 | separation science | SEPCOR UNIT COLLECTION MONITOR | May 7, 1982 |
| K812533 | helmer labs | PLATELET AGITATOR | September 29, 1981 |
| K810617 | lifeline instruments | MOBILE MATIC AUTOMATIC DONOR SCALE | April 7, 1981 |
| K802608 | helmer labs | HEMATIC BLOOD MIXER | December 11, 1980 |
| K800104 | royco instruments | ROYCO MODEL 951 CELL MIXER | February 6, 1980 |
| K780189 | travenol laboratories | PLATELET ROTATOR | March 30, 1978 |
| K760743 | lifeline instruments | DONORMATIC (BLOOD COLLECTION DEVICE) | December 6, 1976 |