510(k) K133322 ยท FRC Indicator, Biological Sterilization Process
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
| Applicant | Steritec Products Mfg Co, Inc., Engelwood CO, US |
| Decision | Substantially Equivalent, Aug 25, 2014 |
| Received | Oct 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133322
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.