The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Automated Blood Cell Separators.
Device ID | BK120082 |
510k Number | BK120082 |
Device Name: | Automated Blood Cell Separators |
Classification | Separator, Automated, Blood Cell, Diagnostic |
Applicant | Fenwal Inc three Corporate Drive 2nd Floor Lake Zurich, IL 60047 |
Product Code | GKT |
CFR Regulation Number | 864.9245 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-12 |
Decision Date | 2013-01-08 |