The following data is part of a premarket notification filed by Dia Tech with the FDA for Centrifuge, Cell-washing, Automated For Immunohematology.
Device ID | BK840001 |
510k Number | BK840001 |
Device Name: | Centrifuge, Cell-Washing, Automated For Immunohematology |
Classification | Centrifuge, Cell-washing, Automated For Immuno-hematology |
Applicant | Dia Tech 2525 Shader Road Orlando, FL 328 |
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 | 1984-02-06 |
Decision Date | 1984-03-19 |