510(k) K173437 ยท FRC Indicator, Biological Sterilization Process
3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H
| Applicant | 3M Company, St. Paul MN, US |
| Decision | Substantially Equivalent, Mar 19, 2018 |
| Received | Nov 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173437
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or
monitor dynamic-air-removal steam sterilization cycles Open, Classified |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.