510(k) K041361 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RANDOX TRI LEVEL CARDIAC CONTROL
| Applicant | Randox Laboratories Limited, Crumlin, GB |
| Decision | Substantially Equivalent, Sep 9, 2004 |
| Received | May 21, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041361
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.