510(k) K081895 ยท LCP Assay, Glycosylated Hemoglobin
ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS
| Applicant | Siemens Medical Solutions Diagnostics, Tarrytown NY, US |
| Decision | Substantially Equivalent, Jan 8, 2009 |
| Received | Jul 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081895
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2014 | Siemens Healthcare Diagnostics ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD
ADVIA Chemistry A1c_3 Calibrator Information: For in v Terminated |
JIX | None listed |
| Sep 3, 2013 | Siemens Healthcare Diagnostics ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators
Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.