510(k) K013068 ยท CGA Glucose Oxidase, Glucose
BIOSCANNER 2000
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 20, 2001 |
| Received | Jun 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2013 | Polymer Technology Systems, Inc. PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers
Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.