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510(k) K890422

Device
ABBOTT TESTPACK(TM) D-DIMER
Applicant
ABBOTT LABORATORIES
510(k) number
K890422
Product code
GHH  
Decision
Substantially Equivalent (SESE)
Decision date
1989-03-27
Date received
1989-01-26
Regulation
864.7320
Classification name
Fibrin Split Products
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARY ZORC
Address
One Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GHH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme Laboratories2013-01-24
K072288PATHFAST D-DIMERMitsubishi Kagaku Iatron2009-05-06
K070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOlympus Life & Material Science Europa GmbH (Irish2007-06-11
K062203TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.2007-03-14
K042890TRIAGE D-DIMER TEST, MODEL 98100Biosite Incorporated2004-11-29
K030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.2003-04-01
K021877MDA D-DIMERbioMerieux, Inc.2002-08-07
K011143TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.2001-05-29
K993276SIMPLIFY D-DIMER, MODEL DCGK1Agen Biomedical , Ltd.1999-12-14
K972316OPUS D-DIMERBehring Diagnostics, Inc.1997-09-09
K945642AGEN DIMERTEST GOLD EIAAgen Biomedical , Ltd.1995-10-25
K921989FDP - SLIDEX DIRECTBiomerieux Vitek, Inc.1993-11-03
K920668MINUTEX D-DIMER LATEX TESTBiopool AB1992-10-16
K905643BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAYAgen Biomedical , Ltd.1991-04-12
K893961ABBOTT IMX(TM) D-DIMERAbbott Laboratories1989-08-03

Legacy Summary#

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FDA Review#

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