K251559
- 510(k) number
- K251559
- Device name
- InstaTRU Instant Biological Indicator for Steam (IBI-05)
- Applicant
- True Indicating, LLC OH · US
- Product code
- QVB — Biological Sterilization Indicator With Indirect Gro
- Decision date
- 2026-06-18
- Date received
- 2025-05-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K251559.pdf
Official FDA record: K251559
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.