510(k) K193406 ยท NBW System, Test, Blood Glucose, Over The Counter
CardioChek Plus Test System; CardioChek Plus Home Test System
| Applicant | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, Whitestown IN, US |
| Decision | Substantially Equivalent, Feb 26, 2022 |
| Received | Dec 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193406
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.