The following data is part of a premarket notification filed by International Business Machines with the FDA for Automated Blood Cell Separator -filtration.
Device ID | BK820001 |
510k Number | BK820001 |
Device Name: | Automated Blood Cell Separator -Filtration |
Classification | Separator, Automated, Blood Cell, Diagnostic |
Applicant | International Business Machines Princeton, NJ 08540 |
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 | 1982-04-19 |
Decision Date | 1982-06-28 |