K250172
- 510(k) number
- K250172
- Device name
- Green Card Bowie-Dick Test (BD115)
- Applicant
- Steritec Products, Inc. (A Getinge Company) CO · US
- Product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Decision date
- 2025-02-20
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K250172.pdf
Official FDA record: K250172
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.