510(k) K140068 ยท NBW System, Test, Blood Glucose, Over The Counter
CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 22, 2015 |
| Received | Jan 13, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2019 | Polymer Technology Systems, Inc. PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700 Terminated |
NBW | None listed |
| Dec 2, 2019 | Polymer Technology Systems, Inc. PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702 Terminated |
NBW | None listed |
| Dec 2, 2019 | Polymer Technology Systems, Inc. Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 Terminated |
NBW | None listed |
| Dec 2, 2019 | Polymer Technology Systems, Inc. Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411 Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.