510(k) K001444 ยท JOJ Indicator, Physical/Chemical Sterilization Process
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
| Applicant | Steritec Products, Inc., Castle Rock CO, US |
| Decision | Substantially Equivalent, May 15, 2000 |
| Received | May 8, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001444
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR
SteriTec Steam Biological Test Packs with Instant Readout Integrat Terminated |
JOJ | None listed |
| Jul 29, 2013 | Steritec Products Mfc. Co., Inc. Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE
SteriTec Steam Biological Test Packs with Instant Readout Inte Terminated |
JOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.