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 | BK090036 |
| 510k Number | BK090036 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Olympus America Inc., Diagnostic Systems Division 3500 Corporate Parkway Center Valley, PA 18034 |
| 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 | 2009-07-27 |
| Decision Date | 2010-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987666535721 | BK090036 | 0 |