510(k) K901216 ยท KXT Enzyme Immunoassay, Digoxin
ENZYMUN TEST(R) DIGOXIN
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 31, 1990 |
| Received | Mar 14, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901216
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.