510(k) K162282 ยท CGA Glucose Oxidase, Glucose
CardioChek Plus Test System, CardioChek Home Test System
| Applicant | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 22, 2016 |
| Received | Aug 15, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162282
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2022 | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. PTS Panels CHOL+GLU Test Strips (REF 1765) Completed |
CGA | None listed |
| Mar 15, 2016 | Polymer Technology Systems, Inc. PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.