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DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DAP
Device Class
Class II
Regulation Number
864.7320
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172903instrumentation laboratoryHemosIL D-Dimer HS 500November 22, 2017
K162227diagnostica stagoSTA® - Liatest® D-DiDecember 10, 2016
K160885instrumentation laboratoryHemosIL D-Dimer HSOctober 27, 2016
K151534instrumentation laboratoryHemosIL D-Dimer HSJuly 6, 2015
K141144diagnostica stagoSTA LIATEST D-DISeptember 3, 2014
K112818biomerieuxVIDAS D-DIMER EXCLUSION II (DEX2)July 31, 2012
K110303siemens healthcare diagnosticsSTRATUS CS ACUTE CARE D-DIMERMay 16, 2011
K093626siemens healthcare diagnosticsINNOVANCE D-DIMER, MODEL OPBP09November 29, 2010
K090264instrumentation laboratoryHEMOSIL D-DIMER HS 500, CONTROLSFebruary 5, 2010
K091916siemens healthcare diagnosticsINNOVANCE D-DIMER, MODEL OPBP09October 29, 2009
K081732siemens healthcare diagnosticsINNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLSOctober 24, 2008
K073042instrumentation laboratoryHEMOSIL D-DIMERJuly 31, 2008
K080069american diagnosticaDIMERTESTFebruary 13, 2008
K070927instrumentation laboratoryHEMOSIL D-DIMER HSSeptember 17, 2007
K063356dade behringSTRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAKMarch 23, 2007
K051597dade behringSTRATUS CS D-DIMERAugust 17, 2005
K050544instrumentation laboratoryHEMOSIL D-DIMER HSApril 26, 2005
K050278instrumentation laboratoryHEMOSIL D-DIMERMarch 10, 2005
K042723biosite incorporatedTRIGAGE PROFILER S.O.B. PANEL, MODEL 97300December 7, 2004
K033491roche diagnosticsROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMERSeptember 1, 2004