510(k) K031226 ยท FRC Indicator, Biological Sterilization Process
STERRAD CYCLESURE BIOLOGICAL INDICATOR
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, May 2, 2003 |
| Received | Apr 18, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2009 | Advanced Sterilization Products Sterrad CycleSure Biological Indicator, Product Code 14324.
The Sterrad CycleSure Biological Indicator is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilizer cy Terminated |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.