510(k) K981493 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
| Applicant | Polymer Technology Systems, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 22, 1998 |
| Received | Apr 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2010 | Polymer Technology Systems, Inc. PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711.
Intended to provi Terminated |
CHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.