510(k) K042015 ยท CGA Glucose Oxidase, Glucose
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
| Applicant | Bayer Healthcare, Diagnostics Division, Tarrytown NY, US |
| Decision | Substantially Equivalent, Sep 29, 2004 |
| Received | Jul 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042015
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.