The following data is part of a premarket notification filed by Olympus America Inc., Diagnostic Systems Division with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK040070 |
| 510k Number | BK040070 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Olympus America Inc., Diagnostic Systems Division 3131 West Royal Lane Irving, TX 75063 |
| 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 | 2004-09-20 |
| Decision Date | 2005-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611969965755 | BK040070 | 0 |
| 07611969965731 | BK040070 | 0 |
| 07611969951499 | BK040070 | 0 |
| 07611969951390 | BK040070 | 0 |
| 07611969951307 | BK040070 | 0 |
| 07611969950898 | BK040070 | 0 |