The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for System, Test, Automated Blood Grouping And Antibody.
| Device ID | BK200549 |
| 510k Number | BK200549 |
| Device Name: | System, Test, Automated Blood Grouping And Antibody |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan, NJ 08869 0606 |
| 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 | 2020-12-18 |
| Decision Date | 2021-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750032846 | BK200549 | 0 |