The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Kit, Quality Control For Blood Banking Reagents.
| Device ID | BK020063 |
| 510k Number | BK020063 |
| Device Name: | Kit, Quality Control For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Beckman Coulter, Inc. 11800 Sw 147 Avenue (m/c: 31-b06) Miami, FL 33196 US |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-27 |
| Decision Date | 2003-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590539788 | BK020063 | 0 |
| 15099590538088 | BK020063 | 0 |