The following data is part of a premarket notification filed by Medsep Corporation with the FDA for Automated Blood Cell Separator -filtration.
Device ID | BK920023 |
510k Number | BK920023 |
Device Name: | Automated Blood Cell Separator -Filtration |
Classification | Separator, Automated, Blood Cell, Diagnostic |
Applicant | Medsep Corporation 2200 Northern Boulevard East Hills, NY 11548 |
Product Code | GKT |
CFR Regulation Number | 864.9245 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-19 |
Decision Date | 1992-10-26 |