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510(k) K890561

Device
SPQ(TM) ANTIBODY REAGENT SET II FOR IGM
Applicant
ATLANTIC ANTIBODIES
510(k) number
K890561
Product code
CFQ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-02-23
Date received
1989-01-24
Regulation
866.5510
Classification name
Radioimmunoassay, Immunoglobulins (g, A, M)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GLENN IRISH
Address
10 Nonesuch Rd. P.O. Box 60 Scarborough ME US 04074 04074

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K990552IMMUNOGLOBULIN A TEST SYSTEMDade 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
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#

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FDA Review#

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