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510(k) K990552

Device
IMMUNOGLOBULIN A TEST SYSTEM
Applicant
DADE BEHRING, INC.
510(k) number
K990552
Product code
CFQ  
Decision
Substantially Equivalent (SESE)
Decision date
1999-03-25
Date received
1999-02-22
Regulation
866.5510
Classification name
Radioimmunoassay, Immunoglobulins (g, A, M)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CATHY P CRAFT
Address
P.O. Box 6101 Rte. 896, Glasgow Bldg. 500 Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CFQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K981786IGA MININEPH ANTISERUMThe Binding Site, Ltd.1999-11-24
K990551IGG FLEX REAGENT CARTRIDGEDade Behring, Inc.1999-03-25
K990553IGM FLEX REAGENT CARTRIDGEDade Behring, Inc.1999-03-22
K951013OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.1995-04-17
K951055OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.1995-04-17
K950900OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.1995-03-27
K891188TITAN GEL IFE TRIVALENT ANTISERUMHelena Laboratories1989-03-22
K890561SPQ(TM) ANTIBODY REAGENT SET II FOR IGMAtlantic Antibodies1989-02-23
K881928MONOCLONAL RADIAL IMMUNODIFFUSION KITThe Binding Site, Ltd.1988-07-08
K881827IMMUNOGLOBULIN A TEST SYSTEMThe Binding Site, Ltd.1988-06-10
K881828IMMUNOGLOBULIN M TEST SYSTEMThe Binding Site, Ltd.1988-06-06

Legacy Summary#

summary

FDA Review#

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