510(k) K013118 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
MODIFICATION TO ALPHA DX SYSTEM
| Applicant | First Medical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 15, 2001 |
| Received | Sep 18, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013118
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.