510(k) K130685 ยท JFJ Catalytic Methods, Amylase
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
| Applicant | Hitachi Chemical Diagnostics, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Aug 9, 2013 |
| Received | Mar 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130685
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.