The following data is part of a premarket notification filed by International Equipment Company with the FDA for Centrifuge, Cell-washing, Automated For Immunohematology.
Device ID | BK940004 |
510k Number | BK940004 |
Device Name: | Centrifuge, Cell-Washing, Automated For Immunohematology |
Classification | Centrifuge, Cell-washing, Automated For Immuno-hematology |
Applicant | International Equipment Company 300 Second Avenue Needham Heights, MA 02194 |
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 | 1993-12-15 |
Decision Date | 1994-04-08 |