The following data is part of a premarket notification filed by Stratec Biomedical Uk Limited with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK160124 |
| 510k Number | BK160124 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | STRATEC Biomedical UK Limited third Ave, Centrum 100 burton Upon Trent Straffordshire, DE14 2WD, UK |
| 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 | 2016-12-27 |
| Decision Date | 2017-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060496770028 | BK160124 | 0 |