510(k) K010456 ยท JFY Enzymatic Method, Creatinine
BIOSCANNER CREATININE TEST STRIPS
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 20, 2001 |
| Received | Feb 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2012 | Polymer Technology Systems, Inc. PTS Panels Creatinine test strips.
PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidne Terminated |
JFY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.