The following data is part of a premarket notification filed by Thermo Electron Led Gmbh (a Subsidiary Of Thermo Fisher Scientific Inc.) with the FDA for Automated Cell-washing Centrifuge For Immune-hematology.
| Device ID | BK160044 |
| 510k Number | BK160044 |
| Device Name: | Automated Cell-washing Centrifuge For Immune-hematology |
| Classification | Centrifuge, Cell-washing, Automated For Immuno-hematology |
| Applicant | Thermo Electron LED GmbH (a Subsidiary Of Thermo Fisher Scientific Inc.) am Kalkberg Osterode Am Harz, Germany, 37520, |
| Product Code | KSN |
| CFR Regulation Number | 864.9285 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-17 |
| Decision Date | 2016-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850685007002 | BK160044 | 0 |