LKO · Class II · 21 CFR 866.5100

FDA Product Code LKO: Anti-rnp Antibody, Antigen And Control

Leading manufacturers include Euroimmun US, Shield Diagnostics, Ltd. and General Biometrics, Inc..

23
Total
23
Cleared
105d
Avg days
1983
Since

FDA 510(k) Cleared Anti-rnp Antibody, Antigen And Control Devices (Product Code LKO)

23 devices
1–23 of 23
Cleared Oct 25, 2019
Maverick RNP Assay and Maverick Diagnostic System
K191085
Genalyte, Inc.
Immunology · 184d
Cleared Dec 09, 2014
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
K140224
Euroimmun US
Immunology · 314d
Cleared Jun 12, 2013
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
K123261
Euroimmun US
Immunology · 237d
Cleared May 28, 2009
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
K083117
Phadia US, Inc.
Immunology · 218d
Cleared Dec 19, 2007
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
K071210
Biomedical Diagnostics (Bmd) SA
Immunology · 232d
Cleared May 09, 2000
RHIGENE MESACUP2 TEST- RNP
K000752
Rhigene, Inc.
Immunology · 62d
Cleared Nov 26, 1999
VARELISA RNP ANTIBODIES
K993589
Pharmacia & Upjohn Co.
Immunology · 35d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SM/RNP ELISA
K990624
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Dec 22, 1998
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476
Bio-Rad
Immunology · 6d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983465
Zeus Scientific, Inc.
Immunology · 48d
Cleared May 08, 1996
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
K954831
Orgentec
Immunology · 201d
Cleared Mar 22, 1996
HYTEC AUTOIMMUNE KITS (RNP)
K954897
Hycor Biomedical, Inc.
Immunology · 185d
Cleared May 11, 1993
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
K930142
Elias U.S.A., Inc.
Immunology · 119d
Cleared May 07, 1991
IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
K911849
General Biometrics, Inc.
Immunology · 11d
Cleared May 07, 1991
IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST
K911850
General Biometrics, Inc.
Immunology · 11d
Cleared Dec 13, 1990
DIASTAT ANTI-LA (SS-B)
K905193
Shield Diagnostics, Ltd.
Immunology · 24d
Cleared Dec 13, 1990
DIASTAT ANTI-RO (SS-A)
K905194
Shield Diagnostics, Ltd.
Immunology · 24d
Cleared Oct 17, 1989
ANTI-RNP AND ANTI-SM ANTIBODY TEST
K895338
Immco Diagnostics, Inc.
Immunology · 47d

About Product Code LKO - Regulatory Context