K241836
- 510(k) number
- K241836
- Device name
- Kem Medical Lead-free Chemical Indicators for Steam Sterilization
- Applicant
- Kem Medical Products Corporation NY · US
- Product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Decision date
- 2024-09-30
- Date received
- 2024-06-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241836.pdf
Official FDA record: K241836
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.