InstaTRU Instant Biological Indicator for Steam (IBI-05)— 510(k) K251559
Substantially EquivalentTrue Indicating, LLC
FDA 510(k) clearance K251559 for InstaTRU Instant Biological Indicator for Steam (IBI-05), Substantially Equivalent on 2026-06-18. Applicant: True Indicating, LLC. Device class: 2.
Clearance details
- Applicant
- True Indicating, LLC
- Product code
- Code QVB
- Device class
- Class 2
- Regulation
- 21 CFR 880.2806
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Toledo, OH, US
Recent devices under product code QVB
view allMore clearances from True Indicating, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.