510(k) BK160044
- Device
- Automated Cell-washing Centrifuge For Immune-hematology
- Applicant
- Thermo Electron LED GmbH (a Subsidiary Of Thermo Fisher Scientific Inc.)
- 510(k) number
- BK160044
- Product code
- KSN
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2016-10-07
- Date received
- 2016-05-17
- Regulation
- 864.9285
- Classification name
- Centrifuge, Cell-washing, Automated For Immuno-hematology
- 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 KSN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K790767 | IMMU-TEK AUTOMATIC CENTRIFUGE | Dade, Baxter Travenol Diagnostics, Inc. | 1979-05-23 |
Legacy Summary#
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FDA Review#
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