510(k) K103277 ยท FRC Indicator, Biological Sterilization Process
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
| Applicant | 3M Company-3M Health Care, St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 19, 2011 |
| Received | Nov 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2014 | 3M Company - Health Care Business 3M Attest Auto-reader. Model numbers 390, 390G,and 490.
These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle. Terminated |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.