510(k) K060369 ยท NQD Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, May 4, 2006 |
| Received | Feb 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer
Catalog Number: CCCRP-C
SMN:10445067 Terminated |
NQD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.