510(k) K012115 ยท FJD Detector, Leak, Blood
SERIM BLOOD LEAK TEST STRIP-2
| Applicant | Serim Research Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Nov 30, 2001 |
| Received | Jul 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012115
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.