510(k) K984067 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 13, 1999 |
| Received | Nov 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984067
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2016 | Siemens Healthcare Diagnostics Inc Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument
that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myo Terminated |
JHX | None listed |
| Nov 10, 2010 | Siemens Healthcare Diagnostics, Inc. Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09
Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer Terminated |
JHX | None listed |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic. Terminated |
JHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.