510(k) K854631 ยท FRC Indicator, Biological Sterilization Process
ASSERT EO BIOLOGICAL TEST PACK
| Applicant | Surgicot, Inc., Smithtown NY, US |
| Decision | Substantially Equivalent, May 27, 1986 |
| Received | Nov 18, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854631
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2013 | Steris Corporation VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH.
Intended for use in installation testing and routine monitoring of steam sterilization and ethy Terminated |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.