510(k) K901135 ยท CFP Radioimmunoassay, Immunoreactive Insulin
ENZYMUN TEST(R) INSULIN
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 3, 1990 |
| Received | Mar 12, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901135
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.