510(k) K142391 ยท JFY Enzymatic Method, Creatinine
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 22, 2014 |
| Received | Aug 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142391
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.