The following data is part of a premarket notification filed by Fenwal, Inc. with the FDA for Automated Blood Cell Separators.
Device ID | BK120041 |
510k Number | BK120041 |
Device Name: | Automated Blood Cell Separators |
Classification | Separator, Automated, Blood Cell, Diagnostic |
Applicant | Fenwal, Inc. three Corporate Drive Lake Zurich, IL 60047 |
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 | 2012-07-12 |
Decision Date | 2012-10-03 |