K984317 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II - Special Controls, product code LGD).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 22, 1999, 50 days after receiving the submission on December 3, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K984317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1998 |
| Decision Date | January 22, 1999 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |