Automated Blood Cell Separators
Separator, Automated, Blood Cell, Diagnostic
Fenwal Inc
The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Automated Blood Cell Separators.
Pre-market Notification Details
Device ID | BK990009 |
510k Number | BK990009 |
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 | 1999-04-05 |
Decision Date | 2000-03-03 |
NIH GUDID Devices
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