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
145–168 of 182
Cleared Nov 05, 1991
ANTI-DSDNA ANTIBODY TEST
K913041
Helix Diagnostics, Inc.
Immunology · 119d
Cleared Sep 23, 1991
ANTI-JO-1 MICROASSAY
K911679
Diamedix Corp.
Immunology · 161d
Cleared Mar 06, 1991
HEMAGEN ENA SCREENING KIT
K910232
Hemagen Diagnostics, Inc.
Immunology · 47d
Cleared Sep 05, 1990
QUANTA LITE TM DSDNA
K903898
Inova Diagnostics, Inc.
Immunology · 14d
Cleared Aug 14, 1990
ANTI-SCI-70 ANTIBODY TEST
K903314
Immco Diagnostics, Inc.
Immunology · 21d
Cleared Aug 09, 1990
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3
K902938
General Biometrics, Inc.
Immunology · 37d
Cleared Aug 09, 1990
IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4
K903047
General Biometrics, Inc.
Immunology · 29d
Cleared May 09, 1990
READS(R) ANTI-ENA (SM/RNP) TEST KIT
K901924
Biosearch Medical Products, Inc.
Immunology · 9d
Cleared Mar 23, 1990
REAADS ANTI-SM TEST KIT
K901230
Biosearch Medical Products, Inc.
Immunology · 9d
Cleared Mar 19, 1990
ANTI-RNP MICROASSAY
K901073
Diamedix Corp.
Immunology · 11d
Cleared Feb 23, 1990
SERATEST ENA [SSA] KIT
K900617
Hemagen Diagnostics, Inc.
Immunology · 15d
Cleared Feb 02, 1990
ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY
K900241
Diamedix Corp.
Immunology · 16d
Cleared Nov 20, 1989
NOVA GEL(TM) T SM/RNP
K896459
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 20, 1989
NOVA GEL(TM) T SS-A/SS-B
K896460
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 20, 1989
NOVA GEL(TM) T SCL-70
K896461
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 20, 1989
NOVA GEL(TM) T JO-1
K896462
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Oct 04, 1989
ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST
K895339
Immco Diagnostics, Inc.
Immunology · 34d
Cleared May 17, 1989
NOVA GEL(TM) JO-1
K892897
Inova Diagnostics, Inc.
Immunology · 27d
Cleared Sep 22, 1988
NOVA LITE(TM) SA
K881341
Inova Diagnostics, Inc.
Immunology · 177d
Cleared Sep 07, 1988
HISTONE REACTIVE ANA
K883232
Val Tech Diagnostics, Inc.
Immunology · 37d
Cleared Jun 08, 1988
NOVA LITE(TM) AUTOANTIBODY CONTROLS
K881340
Inova Diagnostics, Inc.
Immunology · 71d
Cleared Apr 21, 1988
NOVA GEL (TM) SCL-70
K880897
Inova Diagnostics, Inc.
Immunology · 50d
Cleared Apr 21, 1988
NOVA LITE(TM) ANA PLUS
K881339
Inova Diagnostics, Inc.
Immunology · 23d
Cleared Apr 06, 1988
NOVA GEL(TM) SM/RNP
K881181
Inova Diagnostics, Inc.
Immunology · 35d