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510(k) K872800

Device
Tdx Immunoglobulin G Diagnostic Kit
Applicant
ABBOTT LABORATORIES
510(k) number
K872800
Product code
DEW
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-12
Date received
1987-07-15
Regulation
866.5510
Classification name
Igg, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KEITH MINTER
Address
1921 Hurd Dr. P.O.Box 152020 Irving TX US 75015 75015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DEW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050113TINA-QUANT IGG GEN.2Roche Diagnostics Corp.2005-02-08
K040434ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2Roche Diagnostics Corp.2004-03-10
K010617SPIFE IFE CALIBRATOR AND CONTROL KITHelena Laboratories2001-03-15
K993928WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARDWako Chemicals USA, Inc.2000-01-18
K993281K-ASSAY IGGKamiya Biomedical Co.1999-11-09
K983221IGGAbbott Laboratories1998-11-04
K965108SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENTBeckman Instruments, Inc.1997-03-06
K963974IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULINBeckman Instruments, Inc.1997-03-06
K963868IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)Beckman Instruments, Inc.1997-02-10
K962202QUANTEX IGGInstrumentation Laboratory CO1996-09-26
K955798IGG IMMUNOTURBIDIMETRIC & CALIBRATORRandox Laboratories, Ltd.1996-04-05
K951635BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROLBeckman Instruments, Inc.1995-05-15
K943997BEHRING NEPHELOMETER IIBehring Diagnostics, Inc.1994-10-03
K934324OT IGG SORBENTOrganon Teknika Corp.1994-04-21
K933314RADIAS FERRITIN ENZYME IMMUNOASSAYBio-Rad1993-09-08