510(k) K944243 ยท JJT Enzyme Controls (Assayed And Unassayed)
CARDIOCHEX
| Applicant | Cala Diagnostics, Grover Beach CA, US |
| Decision | Substantially Equivalent, Oct 27, 1994 |
| Received | Aug 31, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944243
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.