The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Centrifuge, Blood Bank For In Vitro Diagnostic Use.
| Device ID | BK920034 |
| 510k Number | BK920034 |
| Device Name: | Centrifuge, Blood Bank For In Vitro Diagnostic Use |
| Classification | Centrifuge, Blood-bank For In Vitro Diagnostic Use |
| Applicant | Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan, NJ 08869 US |
| Product Code | KSO |
| CFR Regulation Number | 864.9275 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-06 |
| Decision Date | 1995-05-09 |