The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK190338 |
| 510k Number | BK190338 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 p.o. Box 350 Raritan, NJ 08869 |
| Product Code | KSZ |
| CFR Regulation Number | 864.9175 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-01 |
| Decision Date | 2019-07-09 |