510(k) K040693 ยท MRR System, Test, Low Density, Lipoprotein
PTS PANELS LDL CHOLESTEROL TEST STRIPS
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 6, 2004 |
| Received | Mar 17, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2010 | Polymer Technology Systems, Inc. PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753.
For the quantitativ Terminated |
MRR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.