K234084
- 510(k) number
- K234084
- Device name
- STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count)
- Applicant
- Advanced Sterilization Products, Inc. CA · US
- Product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Decision date
- 2024-07-05
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K234084.pdf
Official FDA record: K234084
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.