K031506 is an FDA 510(k) clearance for the ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II - Special Controls, product code LGD).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on June 2, 2003, 19 days after receiving the submission on May 14, 2003.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K031506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2003 |
| Decision Date | June 02, 2003 |
| Days to Decision | 19 days |
| Submission Type | Special |
| 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 |