510(k) K022898 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
PTS PANELS LIPID PANEL TEST STRIPS
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 24, 2002 |
| Received | Sep 3, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.