510(k) K130915 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
| Applicant | Jas Diagnostics, Inc., Miami Lakes FL, US |
| Decision | Substantially Equivalent, May 15, 2014 |
| Received | Apr 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130915
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.