The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Quality Control Kits For Blood Banking Reagents.
| Device ID | BK820003 |
| 510k Number | BK820003 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan, NJ 08869 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 | 1982-06-30 |
| Decision Date | 1982-08-10 |