The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Automated Blood Cell Separators.
Device ID | BK020059 |
510k Number | BK020059 |
Device Name: | Automated Blood Cell Separators |
Classification | Separator, Automated, Blood Cell, Diagnostic |
Applicant | Baxter Healthcare Corporation 25212 West Ill Route 120 Roundlake, IL 60073 |
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 | 2002-11-20 |
Decision Date | 2003-01-23 |