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510(k) K901637

Device
RESUBMITTED MODIFIED RUBALEX
Applicant
ORION CORP.
510(k) number
K901637
Product code
LQN  
Decision
Substantially Equivalent (SESE)
Decision date
1990-04-26
Date received
1990-04-09
Regulation
866.3510
Classification name
Latex Agglutination Assay, Rubella
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TIMO RAINES
Address
P.O. Box 425 20101 Turku FI

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LQN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K031490RUBELLACOLImmunostics Inc.,2003-07-16
K970931COPALIS TORC TOTAL ANTIBODY ASSAYSienna Biotech, Inc.1997-04-24
K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSSienna Biotech, Inc.1996-10-31
K954920MUREX RUB-EXMurex Diagnostics, Inc.1996-08-21
K952544COLORSLIDER RUBELLASeradyn, Inc.1996-01-17
K912391RUBALEX, MODIFICATIONOrion Corp.1992-05-04
K896433MODIFIED RUBAGENBiokit USA, Inc.1989-11-29
K893755RUBAGENBiokit USA, Inc.1989-08-21
K861881RUBALEX (REVISED VERSION)Orion Corp.1986-06-04
K852788RUBALEXOrion Corp.1986-03-12
K844436VIROGEN RUBELLA MICROTITER TESTArmkel, LLC1985-05-21
K844435VIROGEN RUBELLA SLIDE TESTArmkel, LLC1985-05-20

Legacy Summary#

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FDA Review#

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