510(k) K093794 ยท FRC Indicator, Biological Sterilization Process
SMART-READ EZTEST-STEAM SCBI AND TEST PACK
| Applicant | Sgm Biotech, Inc., Bozeman MT, US |
| Decision | Substantially Equivalent, May 14, 2010 |
| Received | Dec 10, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093794
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2013 | Getinge USA Inc Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 1462 Terminated |
FRC | None listed |
| Aug 1, 2013 | Mesa Laboratories, Inc., Bozeman Manufacturing Facility Mesa Smart-Read 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.