FDA.reportPublic FDA data

510(k) K042629

Device
VARELISA SM ANTIBODIES, MODEL 18296
Applicant
SWEDEN DIAGNOSTICS (GERMANY) GMBH
510(k) number
K042629
Product code
LKP  
Decision
Substantially Equivalent (SESE)
Decision date
2004-12-08
Date received
2004-09-27
Regulation
866.5100
Classification name
Anti-sm Antibody, Antigen And Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SABINE KLUGBAUER
Address
Munzingerstrasse 7 Freiburg DE D-79111 D-79111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LKP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K202067EliA SmDP-SPhadia AB2021-07-14
K183007EliA SmDP ImmunoassayPhadia AB2018-12-24
K132631EIA SMDP IMMUNOASSAYPhadia US, Inc.2014-08-29
K123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,Inova Diagnostics, Inc.2013-04-17
K051066THERATEST EL-ANA PROFILESTheratest Laboratories, Inc.2005-10-07
K024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115Bio-Rad2003-01-15
K013263FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TESTFred Hutchinson Cancer Research Center2002-07-29
K000755RHIGENE MESACUP2 TEST- SMRhigene, Inc.2000-05-09
K000312VARELISA SM ANTIBODIESPharmacia & Upjohn Co.2000-03-17
K990625AUTOSTAT II ANTI-SM ELISACogent Diagnotics , Ltd.1999-04-28
K984479LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208Bio-Rad1998-12-22
K983420THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOOZeus Scientific, Inc.1998-11-18
K980540SERAQUEST ANTI-SMQuest Intl., Inc.1998-06-15
K980811SERAQUEST ANTI-SM/RNPQuest Intl., Inc.1998-05-12
K954830ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAYOrgentec1996-05-08

Legacy Summary#

summary

FDA Review#

Decision Summary