510(k) K071507 ยท NBW System, Test, Blood Glucose, Over The Counter
PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 10, 2007 |
| Received | Jun 1, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071507
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2019 | Polymer Technology Systems, Inc. CHOL+HDL+GLU test strips, REF 2412 Terminated |
CGA | None listed |
| Mar 15, 2016 | Polymer Technology Systems, Inc. PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers Terminated |
NBW | None listed |
| Sep 30, 2010 | Polymer Technology Systems, Inc. PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268. Terminated |
NBW | None listed |
| Mar 5, 2010 | Polymer Technology Systems, Inc. PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.