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510(k) K080069

Device
DIMERTEST
Applicant
AMERICAN DIAGNOSTICA, INC.
510(k) number
K080069
Product code
DAP  
Decision
Substantially Equivalent (SESE)
Decision date
2008-02-13
Date received
2008-01-10
Regulation
864.7320
Classification name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LEIGH AYRES
Address
500 W. Ave. Stamford CT US 06902 06902

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DAP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172903HemosIL D-Dimer HS 500Instrumentation Laboratory CO2017-11-22
K162227STA® - Liatest® D-DiDiagnostica Stago2016-12-10
K160885HemosIL D-Dimer HSInstrumentation Laboratory CO2016-10-27
K151534HemosIL D-Dimer HSInstrumentation Laboratory CO2015-07-06
K141144STA LIATEST D-DIDiagnostica Stago2014-09-03
K112818VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.2012-07-31
K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare Diagnostics2011-05-16
K093626INNOVANCE D-DIMER, MODEL OPBP09Siemens Healthcare Diagnostics2010-11-29
K090264HEMOSIL D-DIMER HS 500, CONTROLSInstrumentation Laboratory CO2010-02-05
K091916INNOVANCE D-DIMER, MODEL OPBP09Siemens Healthcare Diagnostics2009-10-29
K081732INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLSSiemens Healthcare Diagnostics2008-10-24
K073042HEMOSIL D-DIMERInstrumentation Laboratory2008-07-31
K070927HEMOSIL D-DIMER HSInstrumentation Laboratory CO2007-09-17
K063356STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAKDade Behring, Inc.2007-03-23
K051597STRATUS CS D-DIMERDade Behring, Inc.2005-08-17

Legacy Summary#

summary

FDA Review#

Decision Summary