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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 9 of 9 Results
ProductCode: MMI Applicant: DADE BEHRING, INC. Decision Date To: 03/27/2023
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dimension vista ctni flex reagent cartridge DADE BEHRING, INC. K063756 03/19/2007
dimension vista ctni flex flex reagent cartridge, calibrator and sdil sample diluent DADE BEHRING, INC. K053577 04/14/2006
stratus cs acute care mb isoenzyme of creatine kinase (ckmb) test pak; stratus cs acute care ckmb testpak. DADE BEHRING, INC. K051650 09/08/2005
dimension rxl max with streamlab analytical workcell and sample transfer module DADE BEHRING, INC. K043546 01/18/2005
stratus cs acute care troponin i testpak, model cctni DADE BEHRING, INC. K033487 12/24/2003
dimension ctni flex reagent cartridge DADE BEHRING, INC. K010313 04/20/2001
opus troponin i (ctn) test modules DADE BEHRING, INC. K991177 07/01/1999
stratus (r) cs cardiac troponin i (trop) testpak DADE BEHRING, INC. K984093 12/14/1998
stratus cs cardiac troponin i testpak DADE BEHRING, INC. K981098 04/27/1998
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