510(k) K161527 ยท JFY Enzymatic Method, Creatinine
Teco Creatinine Enzymatic Reagent Kit
| Applicant | Teco Diagnostics, Inc., Anaheim CA, US |
| Decision | Substantially Equivalent, Jul 21, 2017 |
| Received | Jun 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161527
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.