K242095
- 510(k) number
- K242095
- Device name
- Access Toxo IgM II
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gond
- Decision date
- 2024-10-11
- Date received
- 2024-07-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K242095.pdf
Official FDA record: K242095
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.