The following data is part of a premarket notification filed by Miltenyi Biotec, Inc. with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
Device ID | BK090020 |
510k Number | BK090020 |
Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | Miltenyi Biotec, Inc. 120 Presidential Way suite 305 Woburn, MA 01801 |
Product Code | KSR |
CFR Regulation Number | 864.9100 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-27 |
Decision Date | 2010-01-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04049934000317 | BK090020 | 0 |
04049934000300 | BK090020 | 0 |
04049934000294 | BK090020 | 0 |
04049934000287 | BK090020 | 0 |
04049934000270 | BK090020 | 0 |