K251035
- 510(k) number
- K251035
- Device name
- DISINTEK PA Test Strips
- Applicant
- Serim Research IN · US
- Product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Decision date
- 2025-06-03
- Date received
- 2025-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251035.pdf
Official FDA record: K251035
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.