The following data is part of a premarket notification filed by Caridianbct with the FDA for Automated Blood Cell Separators.
Device ID | BK090003 |
510k Number | BK090003 |
Device Name: | Automated Blood Cell Separators |
Classification | Separator, Automated, Blood Cell, Diagnostic |
Applicant | CaridianBCT 10811 W. Collins Avenue Lakewood, CO 80215 |
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 | 2009-01-21 |
Decision Date | 2010-02-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
35020583805201 | BK090003 | 0 |
35020583803603 | BK090003 | 0 |
35020583803504 | BK090003 | 0 |
05020583803602 | BK090003 | 0 |
05020583805200 | BK090003 | 0 |
05020583803503 | BK090003 | 0 |