K831930 is an FDA 510(k) clearance for the TOXO-SCREEN DA TEST. This device is classified as a Direct Agglutination Test, Toxoplasma Gondii (Class II - Special Controls, product code LLA).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on September 26, 1983, 103 days after receiving the submission on June 15, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K831930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1983 |
| Decision Date | September 26, 1983 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LLA — Direct Agglutination Test, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |