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510(k) K000880

Device
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
Applicant
ZEUS SCIENTIFIC, INC.
510(k) number
K000880
Product code
LJM  
Decision
Substantially Equivalent (SESE)
Decision date
2000-05-22
Date received
2000-03-20
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
MARK J KOPNITSKY
Address
200 Evans Way Branchburg NJ US 08876 08876

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
K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB2018-11-27
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

Legacy Summary#

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FDA Review#

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