K242538
- 510(k) number
- K242538
- Device name
- 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 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
- 2024-11-25
- Date received
- 2024-08-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242538.pdf
Official FDA record: K242538
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.