510(k) BK820008
- Device
- Device, Blood Mixing And Weighing
- Applicant
- BMT Incorporated
- 510(k) number
- BK820008
- Product code
- KSQ
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1982-10-22
- Date received
- 1982-07-13
- Regulation
- 864.9195
- Classification name
- Device, Blood Mixing And Blood Weighing
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
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 |
| K800104 | ROYCO MODEL 951 CELL MIXER | Royco Instruments | 1980-02-06 |
| K780189 | PLATELET ROTATOR | Travenol Laboratories, S.A. | 1978-03-30 |
| K760743 | DONORMATIC (BLOOD COLLECTION DEVICE) | Lifeline Instruments, Inc. | 1976-12-06 |
Legacy Summary#
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FDA Review#
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