FDA.reportPublic FDA data

510(k) K040811

Device
VARELISA SSDNA ANTIBODIES, MODEL 14896
Applicant
Pharmacia Deutschland GmbH
510(k) number
K040811
Product code
LRM
Decision
Substantially Equivalent (SESE)
Decision date
2004-05-13
Date received
2004-03-29
Regulation
866.5100
Classification name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MICHAEL LINSS
Address
Diagnostics Division Munzinger Strasse 7 Freiburg DE D-79111 D-79111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LRM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K101319IMMULISA DSDNA ANTIBODY ELISAImmco Diagnostics, Inc.2010-12-09
K083381EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)Euroimmun Us, Inc.2009-04-15
K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.2006-11-21
K001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.2000-09-11
K000477MDI DS-DNA TESTMicro Detect, Inc.2000-03-01
K994424DIAMEDIX IS-ANTI-DSDNA TEST SYSTEMDiamedix Corp.2000-02-18
K993727BINDAZYME ANTI-DSDNA EIA KITThe Binding Site, Ltd.1999-12-21
K984396LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213Bio-Rad1998-12-18
K983422THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DETZeus Scientific, Inc.1998-11-18
K980391SERAQUEST ANTI-DSDNAQuest Intl., Inc.1998-04-24
K974694IS-DSDNA TEST SYSTEMDiamedix Corp.1998-03-03
K962730HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODYHycor Biomedical, Inc.1997-03-07
K952567AUTOSTATTMII ANTI-DSDNACogent Diagnotics , Ltd.1997-03-04
K954893HYTEC AUTOMIMMUNE KIT (DS-DNA)Hycor Biomedical, Inc.1996-03-20
K960091ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITHelix Diagnostics, Inc.1996-03-20