K221508
- 510(k) number
- K221508
- Device name
- AnemoCheck Home
- Applicant
- Sanguina, Inc. GA · US
- Product code
- KHG — Whole Blood Hemoglobin Determination
- Decision date
- 2023-09-29
- Date received
- 2022-05-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K221508.pdf
Official FDA record: K221508
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.