510(k) K972035 ยท JOJ Indicator, Physical/Chemical Sterilization Process
SPOROX TEST STRIPS
| Applicant | Serim Research Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Aug 29, 1997 |
| Received | Jun 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972035
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.