510(k) K013173 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 22, 2001 |
| Received | Sep 24, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2019 | Polymer Technology Systems, Inc. Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414 Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.