K240717
- 510(k) number
- K240717
- Device name
- 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- Applicant
- 3M Company MN · US
- Product code
- FRC — Indicator, Biological Sterilization Process
- Decision date
- 2024-06-27
- Date received
- 2024-03-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K240717.pdf
Official FDA record: K240717
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.