FDA.reportPublic FDA data

510(k) K182353

Device
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
Applicant
Phadia AB
510(k) number
K182353
Product code
LJM  
Decision
Substantially Equivalent (SESE)
Decision date
2018-11-27
Date received
2018-08-29
Regulation
866.5100
Classification name
Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carina Magnusson
Address
Rapsgatan 7p Uppsala SE SE 754 50 SE 754 50

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LJM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.2016-03-11
K140493ELIA SCL-70S IMMUNOASSAYPhadia GmbH2014-10-30
K123880QUANTA FLASH CENTROMEREInova Diagnostics, Inc.2014-02-07
K131330GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KITGold Standard Diagnostics2014-01-28
K131185ANA SCREEN ELISA (IGG)Euroimmun US2013-07-15
K083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.2009-03-13
K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbH2005-06-28
K050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH2005-04-26
K041102IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISAImmco Diagnostics, Inc.2004-10-26
K040953AESKULISA ANA HEP-2Aesku, Inc.2004-06-23
K040810VARELISA HISTONE ANTIBODIES, MODEL 16496Pharmacia Deutschland GmbH2004-05-14
K040291EL-ANA PROFILES: ANTI-CHROMATINTheratest Laboratories, Inc.2004-03-11
K040200MESACUP-2 TEST CENP-BRhigene, Inc.2004-03-04
K030929ANA DETECTOrgentec Diagnostika GmbH2003-05-02
K024031THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERETheratest Laboratories, Inc.2003-02-06

Legacy Summary#

summary

FDA Review#

Decision Summary