510(k) K963841 ยท FRC Indicator, Biological Sterilization Process
EZTEST
| Applicant | Sgm Biotech, Inc., Bozeman MT, US |
| Decision | Substantially Equivalent, Feb 25, 1997 |
| Received | Sep 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963841
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.