Device, Blood Mixing And Blood Weighing
This device is a blood mixing and weighing device used in blood banking to agitate blood bags to prevent clotting during collection and to determine the volume of blood collected by measuring the weight of the blood bag. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is KSQ, regulated under 21 CFR 864.9195 within the Hematology specialty. No special flags apply.
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Basic Information
- Product Code
- KSQ
- Device Class
- FDA class 1
- Regulation Number
- 864.9195
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842746 | HYCEL ROTOR-MIXER AND/OR MULTI | Aug 17, 1984 | Substantially Equivalent | R&D Systems, Inc. |
| K820712 | SEPCOR UNIT COLLECTION MONITOR | May 07, 1982 | Substantially Equivalent | Separation Science Corp. |
| K812533 | PLATELET AGITATOR | Sep 29, 1981 | Substantially Equivalent | Helmer Labs, Inc. |
| K810617 | MOBILE MATIC AUTOMATIC DONOR SCALE | Apr 07, 1981 | Substantially Equivalent | Lifeline Instruments, Inc. |
| K802608 | HEMATIC BLOOD MIXER | Dec 11, 1980 | Substantially Equivalent | Helmer Labs, Inc. |
| K800104 | ROYCO MODEL 951 CELL MIXER | Feb 06, 1980 | Substantially Equivalent | Royco Instruments |
| K780189 | PLATELET ROTATOR | Mar 30, 1978 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K760743 | DONORMATIC (BLOOD COLLECTION DEVICE) | Dec 06, 1976 | Substantially Equivalent | Lifeline Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.