K250983
- 510(k) number
- K250983
- Device name
- Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
- Applicant
- Asistan Medikal TR
- Product code
- SCL — Allergen And Vaccine Delivery Needles
- Decision date
- 2026-01-30
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K250983.pdf
Official FDA record: K250983
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.