510(k) K000578 ยท LJX Test, Urine Leukocyte
SERIM LEUKOCYTE ESTERASE TEST STRIPS
| Applicant | Serim Research Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, May 5, 2000 |
| Received | Feb 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000578
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.