510(k) K970546 ยท LFM Enzyme Immunoassay, Digitoxin
ACS DIGITOXIN
| Applicant | Chiron Diagnostics Corp., Medfield MA, US |
| Decision | Substantially Equivalent, Jul 14, 1997 |
| Received | Feb 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2012 | Siemens Healthcare Diagnostics, Inc Siemens Healthcare ADVIA Centaur Digitoxin (DGTN)
250 Test 09046419
50 Test 08861968
Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in s Terminated |
LFM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.