K913467 is an FDA 510(k) clearance for the TOXOGEN. This device is classified as a Direct Agglutination Test, Toxoplasma Gondii (Class II - Special Controls, product code LLA).
Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on January 11, 1993, 525 days after receiving the submission on August 5, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K913467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1991 |
| Decision Date | January 11, 1993 |
| Days to Decision | 525 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LLA — Direct Agglutination Test, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |