The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Toxo-screen Da Test.
| Device ID | K831930 |
| 510k Number | K831930 |
| Device Name: | TOXO-SCREEN DA TEST |
| Classification | Direct Agglutination Test, Toxoplasma Gondii |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington, DC 20006 |
| Product Code | LLA |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-15 |
| Decision Date | 1983-09-26 |