The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Automated Bloodborne Pathogen Test Equipment.
| Device ID | BK050044 |
| 510k Number | BK050044 |
| Device Name: | Automated Bloodborne Pathogen Test Equipment |
| Classification | Test, Equipment, Automated Bloodborne Pathogen |
| Applicant | Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan, NJ 08869 US |
| Product Code | MZA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-08 |
| Decision Date | 2006-11-03 |