K234081
- 510(k) number
- K234081
- Device name
- RedDrop ONE (One)
- Applicant
- Reddrop DX CO · US
- Product code
- FMK — Single Use Only Blood Lancet With An Integral Sharps
- Decision date
- 2024-03-21
- Date received
- 2023-12-22
- Decision
- Unknown
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K234081.pdf
Official FDA record: K234081
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.