510(k) K041750 ยท NBW System, Test, Blood Glucose, Over The Counter
PTS PANELS CHOL+GLU TEST PANEL
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 23, 2004 |
| Received | Jun 29, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041750
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2018 | Polymer Technology Systems, Inc. PTS Panels CHOL+GLU Test Strips (REF 1765) Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.