Atlas FDA

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.

FDA 510(k) clearance K051650 · decided 2005-09-08

Clearance details

K-number
K051650
Device name
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
Applicant
Dade Behring, Inc.
Decision
Substantially Equivalent
Date received
2005-06-21
Decision date
2005-09-08
Days to decision
79 days
Clearance type
Traditional
Product code
JHX
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. recall (Z-1673-2025)Siemens Healthcare Diagnostics Inc2025-04-25
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac tr recall (Z-0609-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement recall (Z-0612-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB is recall (Z-0613-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic recall (Z-0618-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conj recall (Z-0619-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute Care recall (Z-1732-2011)Siemens Healthcare Diagnostics, Inc.2011-03-18
Stratus CS Acute Care Troponin I TestPak ( Troponin I assay) recall (Z-2400-2010)Siemens Healthcare Diagnostics, Inc.2010-09-11
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. recall (Z-0668-2009)Dade Behring, Inc.2009-01-28

PMA approvals by this applicant

RecordFirmDate
COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003)Dade Behring, Inc.2002-07-24
COBAS INTEGRA CYCLOSPORINE (P920031/S002)Dade Behring, Inc.2002-02-26
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001)Dade Behring, Inc.2000-08-11
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031)Dade Behring, Inc.1996-10-02