510(k) K041427 ยท CGA Glucose Oxidase, Glucose
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
| Applicant | Arkray, Inc., Cortlandt Manor NY, US |
| Decision | Substantially Equivalent, Nov 24, 2004 |
| Received | May 28, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2016 | Arkray Factory USA, Inc. arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424.
For the in vitro quantitative determination of glucose in human plasma from whole blood samples. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.