K243501
- 510(k) number
- K243501
- Device name
- 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M
- Applicant
- 3M Company MN · US
- Product code
- FRC — Indicator, Biological Sterilization Process
- Decision date
- 2025-01-28
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243501.pdf
Official FDA record: K243501
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.