K250555
- 510(k) number
- K250555
- Device name
- MallyaD injection pen adapter (MallyaD)
- Applicant
- Biocorp Production FR
- Product code
- QOG — Injection Data Capture Device
- Decision date
- 2025-03-27
- Date received
- 2025-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250555.pdf
Official FDA record: K250555
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.