K240800
- 510(k) number
- K240800
- Device name
- Access Intrinsic Factor Ab
- Applicant
- Beckman Coulter, Inc. MN · US
- Product code
- LIG — Radioassay, Intrinsic Factor Blocking Antibody
- Decision date
- 2024-05-03
- Date received
- 2024-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240800.pdf
Official FDA record: K240800
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.