510(k) K051650 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 8, 2005 |
| Received | Jun 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051650
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2025 | Siemens Healthcare Diagnostics Inc Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. Open, Classified |
JHX | None listed |
| May 29, 2019 | Siemens Healthcare Diagnostics Inc Stratus CS Acute Care cTNI TestPak, SMN 10445071
Product Usage:
In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used a Terminated |
MMI | None listed |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma
Catalog Number: CCTNI
SMN: 10445071 Terminated |
MMI | None listed |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized plasma
Catalog Number: CMYO
SMN:10445079 Terminated |
DDR | None listed |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma
Cat Terminated |
JHX | None listed |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care MYO DilPak
Catalog Number: CMYO-D
SMN:10445081
in vitro diagnostic Terminated |
DDR | None listed |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak
Catalog Number: CCKMB-D
SMN: 10445070 Terminated |
JHX | None listed |
| Mar 18, 2011 | Siemens Healthcare Diagnostics, Inc. Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay
The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the measurement of cardiac Troponin I in hepar Terminated |
MMI | None listed |
| Sep 11, 2010 | Siemens Healthcare Diagnostics, Inc. Stratus CS Acute Care Troponin I TestPak ( Troponin I assay) Terminated |
MMI | None listed |
| Jan 28, 2009 | Dade Behring, Inc. Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. Terminated |
JHX | None listed |
| Apr 28, 2008 | Siemens Healthcare Diagnostics, Inc. Siemens Stratus CS Acute Care Troponin I CalPak.
In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer. Terminated |
MMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.