510(k) K071593 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
PTS PANELS CHOL+HDL PANEL TEST STRIPS
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 15, 2007 |
| Received | Jun 11, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071593
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2010 | Polymer Technology Systems, Inc. PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795.
The product is used to meas Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.