LKO · Class II · 21 CFR 866.5100

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

Leading manufacturers include Shield Diagnostics, Ltd., Genalyte, Inc. and Immco Diagnostics, 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 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 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 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