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510(k) K004019

Device
ANA EIA DIAGNOSTIC TEST KIT
Applicant
The Binding Site, Ltd.
510(k) number
K004019
Product code
LJM
Decision
Substantially Equivalent (SESE)
Decision date
2001-02-15
Date received
2000-12-27
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
Statement
Third party reviewed
N

Applicant Contact#

Contact
JAY H GELLER
Address
West Tower, Suite 4000 2425 W. Olympic Blvd. Santa Monica CA US 90404 90404

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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