510(k) K800104
- Device
- Royco Model 951 Cell Mixer
- Applicant
- ROYCO INSTRUMENTS
- 510(k) number
- K800104
- Product code
- KSQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-02-06
- Date received
- 1980-01-16
- Regulation
- 864.9195
- Classification name
- Device, Blood Mixing And Blood Weighing
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010773581
- 3043088937
- 3004973569
- 3004548776
- 3008810357
- 3004634229
- 2951275
- 3006611221
- 3042989733
- 3031700059
- 2248588
- 3027645317
- 3043138885
- 3012315023
- 3002821232
- 3005778453
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KSQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842746 | HYCEL ROTOR-MIXER AND/OR MULTI | R&D Systems, Inc. | 1984-08-17 |
| K820712 | SEPCOR UNIT COLLECTION MONITOR | Separation Science Corp. | 1982-05-07 |
| K812533 | PLATELET AGITATOR | Helmer Labs, Inc. | 1981-09-29 |
| K810617 | MOBILE MATIC AUTOMATIC DONOR SCALE | Lifeline Instruments, Inc. | 1981-04-07 |
| K802608 | HEMATIC BLOOD MIXER | Helmer Labs, Inc. | 1980-12-11 |
| K780189 | PLATELET ROTATOR | Travenol Laboratories, S.A. | 1978-03-30 |
| K760743 | DONORMATIC (BLOOD COLLECTION DEVICE) | Lifeline Instruments, Inc. | 1976-12-06 |