LLL · Class II · 21 CFR 866.5100

FDA Product Code LLL: Extractable Antinuclear Antibody, Antigen And Control

Leading manufacturers include Inova Diagnostics, Inc., Hemagen Diagnostics, Inc. and Hycor Biomedical, Inc..

182
Total
182
Cleared
110d
Avg days
1981
Since
182 devices
121–144 of 182
Cleared Mar 23, 1993
RHEUMELISA II SCL-70 ANTIBODY TEST KIT
K930130
Biowhittaker Molecular Applications, Inc.
Immunology · 70d
Cleared Mar 04, 1993
QUANTA LITE(TM) JO-1 ELISA KIT
K926562
Inova Diagnostics, Inc.
Immunology · 63d
Cleared Feb 02, 1993
EN TYPING CIE KIT FOR DIAGNOSTIC USE
K925118
The Binding Site, Ltd.
Immunology · 162d
Cleared Dec 29, 1992
ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
K924262
The Binding Site, Ltd.
Immunology · 127d
Cleared Dec 15, 1992
QUANTA LITE(TM) SCL-70 ELISA
K924898
Inova Diagnostics, Inc.
Immunology · 78d
Cleared Dec 01, 1992
ENCORE SM
K921572
Clark Laboratories, Inc.
Immunology · 243d
Cleared Dec 01, 1992
ENCORE SM/RNP
K921870
Clark Laboratories, Inc.
Immunology · 225d
Cleared Dec 01, 1992
IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
K924843
General Biometrics, Inc.
Immunology · 64d
Cleared Nov 30, 1992
AUTOZYME
K922241
Cambridge Life Sciences Plc.
Immunology · 201d
Cleared Oct 16, 1992
ENCORE SS-B
K922340
Clark Laboratories, Inc.
Immunology · 150d
Cleared Oct 13, 1992
ENCORE SS-A
K922157
Clark Laboratories, Inc.
Immunology · 159d
Cleared Sep 18, 1992
QUANTA LITE ENA ELISA
K922829
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SS-A ELISA
K922830
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SM ELISA
K922831
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SS-B ELISA
K922832
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE RNP ELISA
K922833
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Apr 07, 1992
HEMAGEN ENA [JO-1] KIT (EIA METHOD)
K915420
Hemagen Diagnostics, Inc.
Immunology · 127d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST [SS-A (RO)]
K920383
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANIT-ENA ANTIBODY TEST [SS-B (LA)]
K920384
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST (SM)
K920385
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST KIT
K920386
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Feb 12, 1992
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K915282
Hemagen Diagnostics, Inc.
Immunology · 79d
Cleared Dec 20, 1991
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K915058
Hemagen Diagnostics, Inc.
Immunology · 42d
Cleared Dec 20, 1991
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
K915234
Hemagen Diagnostics, Inc.
Immunology · 28d