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510(k) K943098

Device
HUMAN IGG SUBCLASSES ELISA COMBI KIT
Applicant
RESEARCH DIAGNOSTICS, INC.
510(k) number
K943098
Product code
DAS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-07
Date received
1994-06-28
Regulation
866.5530
Classification name
Igg (fc Fragment Specific), Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRET WIEN
Address
Pleasant Hill Rd. Flanders NJ US 07836 07836

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DAS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K982023PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KITInova Diagnostics, Inc.1998-09-04
K944876HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KITResearch Diagnostics, Inc.1994-12-15
K943205HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)Research Diagnostics, Inc.1994-09-07
K895600HUMAN (IGG) SUBCLASS (EIA) KITThe Binding Site, Ltd.1989-11-08
K790708ANTISERUM TO HUMAN IG G FC FRAGMENTSKent Laboratories, Inc.1979-08-22
K790715ANTISERUM TO HUMAN FCKent Laboratories, Inc.1979-08-16
K761156AMINOGLYCOSIDE CONTROLSSupelco, Inc.1976-12-09

Legacy Summary#

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FDA Review#

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