510(k) K111150 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, Jul 8, 2011 |
| Received | Apr 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111150
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638
The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed Terminated |
FRC | None listed |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639
The Smart-Read Biological Test Pack with Instant Readout Integrator: is desi Terminated |
FRC | None listed |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25
The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed spec Terminated |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.