The following data is part of a premarket notification filed by Chartermed, Inc. with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
| Device ID | BK960043 | 
| 510k Number | BK960043 | 
| Device Name: | Empty Containers 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 | 1996-04-11 | 
| Decision Date | 1996-09-11 | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 00817827025792 | BK960043 | 0 | 
| 00817827025631 | BK960043 | 0 | 
| 00817827025624 | BK960043 | 0 | 
| 00817827025617 | BK960043 | 0 | 
| 00817827025600 | BK960043 | 0 | 
| 00817827025594 | BK960043 | 0 | 
| 00817827025587 | BK960043 | 0 | 
| 00817827025570 | BK960043 | 0 | 
| 00817827025563 | BK960043 | 0 | 
| 00817827025556 | BK960043 | 0 | 
| 00817827025549 | BK960043 | 0 | 
| 00817827025532 | BK960043 | 0 | 
| 00817827025525 | BK960043 | 0 | 
| 00817827025648 | BK960043 | 0 | 
| 00817827025655 | BK960043 | 0 | 
| 00817827025662 | BK960043 | 0 | 
| 00817827025785 | BK960043 | 0 | 
| 00817827025778 | BK960043 | 0 | 
| 00817827025761 | BK960043 | 0 | 
| 00817827025754 | BK960043 | 0 | 
| 00817827025747 | BK960043 | 0 | 
| 00817827025730 | BK960043 | 0 | 
| 00817827025723 | BK960043 | 0 | 
| 00817827025716 | BK960043 | 0 | 
| 00817827025709 | BK960043 | 0 | 
| 00817827025693 | BK960043 | 0 | 
| 00817827025686 | BK960043 | 0 | 
| 00817827025679 | BK960043 | 0 | 
| 00817827025518 | BK960043 | 0 |