The following data is part of a premarket notification filed by Biotest Medical Diagnostics Gmbh with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK080013 |
| 510k Number | BK080013 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Biotest Medical Diagnostics GmbH p.o. Box 10 21 50 63267 Dreiech, GM |
| 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 | 2008-03-17 |
| Decision Date | 2008-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611969961696 | BK080013 | 0 |
| 07611969951468 | BK080013 | 0 |
| 07611969951352 | BK080013 | 0 |