K162678 is an FDA 510(k) clearance for the Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II - Special Controls, product code LGD).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on June 23, 2017, 270 days after receiving the submission on September 26, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K162678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2016 |
| Decision Date | June 23, 2017 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |