510(k) K930682 ยท FRC Indicator, Biological Sterilization Process
EZTEST-STEAM
| Applicant | Sgm Biotech, Inc., Bozeman MT, US |
| Decision | Substantially Equivalent, Apr 4, 1994 |
| Received | Feb 10, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K930682
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2013 | Mesa Laboratories, Inc., Bozeman Manufacturing Facility Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM.
Intended for use in determining the efficacy of steam sterilization processes. Terminated |
FRC | None listed |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525
EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Bio Terminated |
FRC | None listed |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ
EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biol Terminated |
FRC | None listed |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400
EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended fo Terminated |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.