The following data is part of a premarket notification filed by Chartermed, Inc. with the FDA for Container, Empty, For The Collection '& Processing Of Blood/blood Components.
| Device ID | BK910003 |
| 510k Number | BK910003 |
| Device Name: | Container, Empty, For The Collection '& Processing Of Blood/Blood Components |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | CharterMed, Inc. 3948-a West Point Blvd. Winston-salem, NC 27103 |
| 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 | 1991-02-08 |
| Decision Date | 1993-03-11 |