510(k) K982188 ยท JOJ Indicator, Physical/Chemical Sterilization Process
STERI-PAK BOWIE DICK TEST PACK
| Applicant | Steritec Products Mfg Co, Inc., Castle Rock CO, US |
| Decision | Substantially Equivalent, Nov 20, 1998 |
| Received | Jun 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2020 | Resource Optimization & Innovation LLC regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of s Terminated |
JOJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.