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510(k) K891990

Device
RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
Applicant
CLINICAL SCIENCES, INC.
510(k) number
K891990
Product code
LJB  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-15
Date received
1989-03-28
Regulation
866.3520
Classification name
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HELEN SCHNEIDER
Address
30 Troy Rd. Whippany NJ US 07981 07981

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974552DIAMEDIX IS-MEASLES IGG TEST SYSTEMDiamedix Corp.1998-01-28
K971620QUANTA LITE RUBEOLA (MEASLES) IGGInova Diagnostics, Inc.1997-07-22
K922330BARTELS RUBEOLA IGG EIABaxter Diagnostics, Inc.1992-09-02
K922335BARTELS RUBEOLA IGM EIABaxter Diagnostics, Inc.1992-09-02
K910290VIRATEST-DIA(TM) MEASLES (RUBEOLA)Virus Reference Laboratory, Inc.1992-03-18
K904083RUBEOLA IGM ELISA TESTGull Laboratories, Inc.1991-01-03
K903961MEASLES IGG MICROASSAYDiamedix Corp.1990-12-28
K904854RUBEOLA IGG ELISA TESTGull Laboratories, Inc.1990-12-04
K873925VIRGO(TM) MEASLES IGG ELISAElectro-Nucleonics Laboratories, Inc.1988-02-24
K821762MEASELISA TEST KITM.A. Bioproducts1982-07-30

Legacy Summary#

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FDA Review#

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