510(k) K023558 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
PTS PANELS LIPID PANEL TEST STRIPS
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 15, 2002 |
| Received | Oct 23, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023558
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2019 | Polymer Technology Systems, Inc. Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412 Terminated |
CHH | None listed |
| Mar 15, 2010 | Polymer Technology Systems, Inc. PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710. Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.