K242453
- 510(k) number
- K242453
- Device name
- Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
- Applicant
- Terragene S.A. AR
- Product code
- FRC — Indicator, Biological Sterilization Process
- Decision date
- 2024-12-12
- Date received
- 2024-08-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242453.pdf
Official FDA record: K242453
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.