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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K051650
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Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the... 2 07/30/2019 Siemens Healthcare Diagnostics Inc
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglob... 2 01/07/2016 Siemens Healthcare Diagnostics Inc
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme o... 2 01/07/2016 Siemens Healthcare Diagnostics Inc
Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic 2 01/07/2016 Siemens Healthcare Diagnostics Inc
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I ... 2 01/07/2016 Siemens Healthcare Diagnostics Inc
Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction wi... 2 01/07/2016 Siemens Healthcare Diagnostics Inc
Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibra... 2 06/25/2015 Siemens Healthcare Diagnostics, Inc.
Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Trop... 2 03/18/2011 Siemens Healthcare Diagnostics, Inc.
Stratus CS Acute Care Troponin I TestPak ( Troponin I assay) 2 09/11/2010 Siemens Healthcare Diagnostics, Inc.
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. 2 01/28/2009 Dade Behring, Inc.
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