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510(k) K974604

Device
RANDOX IRON
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K974604
Product code
JMO  
Decision
Substantially Equivalent (SESE)
Decision date
1998-01-06
Date received
1997-12-10
Regulation
862.1415
Classification name
Ferrozine (colorimetric) Iron Binding Capacity
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
P ARMSTRONG
Address
55 Diamond Rd. Crumlin, Co. Antrim IE BT29 4QY BT29 4QY

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JMO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K113438ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.2012-06-01
K061464VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668Ortho-Clinical Diagnostics, Inc.2006-06-15
K052867VITROS CHEMISTRY PRODUCTS DTIBC REAGENTOrtho-Clinical Diagnostics, Inc.2005-12-23
K041793OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524Olympus America, Inc.2004-07-16
K013102WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002Wiener Laboratories Saic2001-11-13
K012340BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)Bayer Corp.2001-10-01
K000781DIRECT TIBC KITReference Diagnostics, Inc.2000-05-02
K994115TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGEDade Behring, Inc.2000-01-28
K991666TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02A.P. Total Care, Inc.1999-06-30
K991244TOTAL IRON, MODELS FE 109-01, FE 109-02A.P. Total Care, Inc.1999-05-25
K990216MAGNETIC TIBC KITReference Diagnostics, Inc.1999-02-16
K982041UIBCAbbott Laboratories1998-07-30
K981654TIBCAbbott Laboratories1998-07-22
K981279TIBCAbbott Laboratories1998-05-20
K961587IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25Diagnostic Chemicals , Ltd.1996-08-27

Legacy Summary#

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FDA Review#

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