510(k) K110934 ยท LCP Assay, Glycosylated Hemoglobin
ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
| Applicant | Siemens Healthcare Diagnostics, East Walpole MA, US |
| Decision | Substantially Equivalent, Aug 25, 2011 |
| Received | Apr 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110934
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2016 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federati Terminated |
LCP | None listed |
| Nov 25, 2015 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobi Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.