510(k) K103222 ยท FRC Indicator, Biological Sterilization Process
STERRAD CYCLESURE BIOLOGICAL INDICATOR
| Applicant | Advanced Sterilization Products, Irvin CA, US |
| Decision | Substantially Equivalent, Feb 25, 2011 |
| Received | Nov 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103222
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2013 | Advanced Sterilization Products STERRAD Cyclesure Biological Indicator (BI, Part No. 14324.
Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. Terminated |
FRC | None listed |
| Dec 12, 2012 | Advanced Sterilization Products STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324.
Validation kits with Sterrad Cyclesure 24 BI products:
Codes/Serial Numbers, Product Description:
14324 Sterrad Cyclesure 24 Biol Terminated |
FRC | None listed |
| Jul 27, 2012 | Advanced Sterilization Products STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs.
The STERRAD CYCLESURE 24 Biological Indicator (BI) Terminated |
FRC | None listed |
| Jun 6, 2012 | Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator, P/N: 14324
The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization Sy Terminated |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.