510(k) K951888 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
DADE STRATUS TROPONIN-I CONTROL
| Applicant | Dade Intl., Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 13, 1995 |
| Received | Apr 24, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951888
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.