510(k) K182781 ยท CGA Glucose Oxidase, Glucose
PTS Professional Chemistry Kit
| Applicant | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, Indianapolis IN, US |
| Decision | Unknown, Dec 21, 2018 |
| Received | Oct 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182781
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2019 | Polymer Technology Systems, Inc. CHOL+HDL+GLU test strips, REF 2412 Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.