510(k) K151545 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 22, 2016 |
| Received | Jun 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2019 | Polymer Technology Systems, Inc. PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips
Ref Number: 1710
Product Usage:
PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholester Terminated |
CHH | None listed |
| Jun 7, 2019 | Polymer Technology Systems, Inc. Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips
Ref Number: 570-0414
Product Usage:
PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprote Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.