510(k) K151530 ยท CGA Glucose Oxidase, Glucose
CardioChek Plus Test System
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 7, 2015 |
| Received | Jun 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151530
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.