510(k) K911628 ยท LIF Dialyzer Reprocessing System
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
| Applicant | Serim Research Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Jun 27, 1991 |
| Received | Apr 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911628
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.