K863363 is an FDA 510(k) clearance for the CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II - Special Controls, product code LGD).
Submitted by Cytotech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 13, 1986, 72 days after receiving the submission on September 2, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K863363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1986 |
| Decision Date | November 13, 1986 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |