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510(k) K982023

Device
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
Applicant
INOVA DIAGNOSTICS, INC.
510(k) number
K982023
Product code
DAS  
Decision
Substantially Equivalent (SESE)
Decision date
1998-09-04
Date received
1998-06-09
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
BRYS C MYERS
Address
10180 Scripps Ranch Blvd. San Diego CA US 92131 92131

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
K944876HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KITResearch Diagnostics, Inc.1994-12-15
K943098HUMAN IGG SUBCLASSES ELISA COMBI KITResearch Diagnostics, Inc.1994-09-07
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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