KSQ · Device, Blood Mixing And Blood Weighing
Hematology · 21 CFR 864.9195 · Class 1
Overview
| Product Code | KSQ |
|---|---|
| Device Name | Device, Blood Mixing And Blood Weighing |
| Regulation | 21 CFR 864.9195 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected.
Classification Rationale
Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K842746 | HYCEL ROTOR-MIXER AND/OR MULTI | R&D Systems, Inc. | Aug 17, 1984 | SESE |
| K820712 | SEPCOR UNIT COLLECTION MONITOR | Separation Science Corp. | May 7, 1982 | SESE |
| K812533 | PLATELET AGITATOR | Helmer Labs, Inc. | Sep 29, 1981 | SESE |
| K810617 | MOBILE MATIC AUTOMATIC DONOR SCALE | Lifeline Instruments, Inc. | Apr 7, 1981 | SESE |
| K802608 | HEMATIC BLOOD MIXER | Helmer Labs, Inc. | Dec 11, 1980 | SESE |
| K800104 | ROYCO MODEL 951 CELL MIXER | Royco Instruments | Feb 6, 1980 | SESE |
| K780189 | PLATELET ROTATOR | Travenol Laboratories, S.A. | Mar 30, 1978 | SESE |
| K760743 | DONORMATIC (BLOOD COLLECTION DEVICE) | Lifeline Instruments, Inc. | Dec 6, 1976 | SESE |
Top Applicants
- Helmer Labs, Inc. — 2 clearances
- Lifeline Instruments, Inc. — 2 clearances
- R&D Systems, Inc. — 1 clearance
- Royco Instruments — 1 clearance
- Separation Science Corp. — 1 clearance
