Home / Device Classification / LKO

LKO — Anti-Rnp Antibody, Antigen And Control Class II

FDA Device Classification

Classification Details

Product Code
LKO
Device Class
Class II
Regulation Number
866.5100
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K191085genalyteMaverick RNP Assay and Maverick Diagnostic SystemOctober 25, 2019
K140224euroimmun usEUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)December 9, 2014
K123261euroimmun usEUROIMMUN ANTI-NRNP/SM ELISA (IGG)June 12, 2013
K083117phadia usELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELMay 28, 2009
K071210biomedical diagnostics (bmd)MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006December 19, 2007
K022017rhigeneRHIGENE MESACUP-2 TEST RNP, MODEL M7741August 14, 2002
K000752rhigeneRHIGENE MESACUP2 TEST- RNPMay 9, 2000
K993589pharmacia and upjohnVARELISA RNP ANTIBODIESNovember 26, 1999
K990624cogent diagnoticsAUTOSTAT II ANTI-SM/RNP ELISAApril 28, 1999
K984476bio-radLIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207December 22, 1998
K983465zeus scientificTHE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINNovember 18, 1998
K954831orgentecORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAYMay 8, 1996
K954897hycor biomedicalHYTEC AUTOIMMUNE KITS (RNP)March 22, 1996
K940588helix diagnosticsENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KITApril 20, 1994
K930142elias u.s.aSYNELISA U1-SNRNP (68KDA)-ANTIBODIESMay 11, 1993
K911850general biometricsIMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TESTMay 7, 1991
K911849general biometricsIMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TESTMay 7, 1991
K905193shield diagnosticsDIASTAT ANTI-LA (SS-B)December 13, 1990
K905194shield diagnosticsDIASTAT ANTI-RO (SS-A)December 13, 1990
K895997lipogenRHEUMELISA ASSAY FOR RNP AUTOANTIBODIESNovember 6, 1989