The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Automated Blood Cell Separators.
Device ID | BK030085 |
510k Number | BK030085 |
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 | 2003-12-16 |
Decision Date | 2004-03-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04086000100137 | BK030085 | 0 |
04086000100120 | BK030085 | 0 |