510(k) K173519 ยท FRC Indicator, Biological Sterilization Process
3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader
| Applicant | 3M Company, St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 23, 2018 |
| Received | Nov 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2023 | 3M Company - Health Care Business 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes Open, Classified |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.