K231383
- 510(k) number
- K231383
- Device name
- Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- Applicant
- Terragene S.A. AR
- Product code
- FRC — Indicator, Biological Sterilization Process
- Decision date
- 2024-09-18
- Date received
- 2023-05-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231383
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.