510(k) K964264 ยท FKP System, Dialysate Delivery, Single Patient
HIGH RANGE PEROXIDE TEST STRIP
| Applicant | Integrated Biomedical Technology, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Jun 16, 1997 |
| Received | Oct 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964264
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.