K080869 is an FDA 510(k) clearance for the ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC. 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 May 23, 2008, 53 days after receiving the submission on March 31, 2008.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K080869 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2008 |
| Decision Date | May 23, 2008 |
| Days to Decision | 53 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 |