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510(k) K981581

Device
Iron
Applicant
ABBOTT LABORATORIES
510(k) number
K981581
Product code
CFM
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-08
Date received
1998-05-04
Regulation
862.1410
Classification name
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARK LITTLEFIELD
Address
Dept. 09va Lc-2 1920 Hurd Dr. Irving TX US 75038 75038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CFM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K984119WAKO L-TYPE FE, WAKO L-TYPE CALIBRATORWako Chemicals USA, Inc.1999-01-15
K932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERCatachem, Inc.1993-09-08
K913705ABBOTT QLUICKSTART IRON TEST, ITEM #5A29Em Diagnostic Systems, Inc.1991-10-09
K912912SYNERMED SERUM IRON-600 REAGENT KITSynermed, Inc.1991-07-30
K902918SYNERMED SERUM IRON REAGENT KITSynermed, Inc.1990-07-31
K895047CLINISTAT POTASSIUM REAGENT TESTHeraeus Kulzer, Inc.1989-10-17
K891155IRON REAGENTMedical Analysis Systems, Inc.1989-04-18
K873120ABBOTT A-GENT IRON REAGENT KITAbbott Laboratories1987-08-25
K861602TOTAL IRON BINDING CAPACITY PROCEDUREData Medical Associates, Inc.1986-05-23
K854305DART IRON & IRON BINDING CAPACITY REAGENTCoulter Electronics, Inc.1985-11-12
K852583DATA CHEM IRON PROCEDUREData Medical Associates, Inc.1985-07-12
K842505TDX REA IRON DIAGNOSTIC KITAbbott Laboratories1984-08-07
K842156SERUM IRON & SERUM IRON BINDING CAPACITYDiagnostic Chemicals, Ltd. (Usa)1984-08-07
K842155SERUM IRON & SERUM IRON BINDING CAPACIDiagnostic Chemicals, Ltd. (Usa)1984-08-07
K840485TOTAL IRON UIBC/TIBC ASSAYSomas Medical Industries, Inc.1984-03-12