510(k) K003341 ยท KLB Radioimmunoassay, Tobramycin
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
| Applicant | Syva Co., Dade Behring, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jan 22, 2001 |
| Received | Oct 25, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003341
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.