The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK850001 |
| 510k Number | BK850001 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Gamma Biologicals, Inc. 3700 Mangum Road Houston, TX 77092 |
| 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 | 1984-12-26 |
| Decision Date | 1985-04-05 |