Quality Control Kits For Blood Banking Reagents
Kit, Quality Control For Blood Banking Reagents
American Red Cross
The following data is part of a premarket notification filed by American Red Cross with the FDA for Quality Control Kits For Blood Banking Reagents.
Pre-market Notification Details
| Device ID | BK120042 |
| 510k Number | BK120042 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | American Red Cross diagnostic Manufacturing Division 2025 E Street Nw Washington, DC 20006 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 | 2012-07-20 |
| Decision Date | 2012-10-06 |
NIH GUDID Devices
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