K210596 is an FDA 510(k) clearance for the ARCHITECT Toxo IgG. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II - Special Controls, product code LGD).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 19, 2022, 444 days after receiving the submission on March 1, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K210596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2021 |
| Decision Date | May 19, 2022 |
| Days to Decision | 444 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 |