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510(k) K070453

Device
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
Applicant
OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH
510(k) number
K070453
Product code
GHH  
Decision
Substantially Equivalent (SESE)
Decision date
2007-06-11
Date received
2007-02-16
Regulation
864.7320
Classification name
Fibrin Split Products
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
STEPHANIE G SCHWARTZ
Address
3131 W. Royal Ln. Irving TX US 75063 75063

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K890422ABBOTT TESTPACK(TM) D-DIMERAbbott Laboratories1989-03-27

Legacy Summary#

summary

FDA Review#

Decision Summary