510(k) K081294 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 29, 2008 |
| Received | May 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081294
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2019 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase hsCRP Terminated |
JIX | None listed |
| Nov 19, 2019 | Siemens Healthcare Diagnostics, Inc. Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase hsCRP assay Terminated |
JIX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.