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..

181
Total
181
Cleared
109d
Avg days
1981
Since
181 devices
97–120 of 181
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 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
Cleared Mar 25, 1988
NOVA LITE(TM) ANA
K880736
Inova Diagnostics, Inc.
Immunology · 30d
Cleared Mar 25, 1988
NOVA GEL(TM) SS-A/SS-B
K880896
Inova Diagnostics, Inc.
Immunology · 23d
Cleared Aug 12, 1987
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
K871994
Behring Diagnostics, Inc.
Immunology · 78d
Cleared Aug 19, 1986
SERATEST ENA [SS-B] KIT
K862700
Hemagen Diagnostics, Inc.
Immunology · 35d
Cleared Jul 29, 1986
KALLESTAD SSA/SSB ENA TEST REAGENTS
K862710
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared May 15, 1986
SM-RNP AUTOANTIBODY TEST SYSTEM
K860428
Immuno Concepts, Inc.
Immunology · 100d
Cleared Mar 28, 1986
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
K860644
Immuno Concepts, Inc.
Immunology · 36d
Cleared Feb 26, 1985
PHYSIO GAS ANALYZER
K843423
Research Medical, Inc.
Immunology · 179d
Cleared Dec 18, 1984
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
K843978
Behring Diagnostics, Inc.
Immunology · 68d
Cleared May 22, 1984
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
K840221
Zeus Scientific, Inc.
Microbiology · 124d
Cleared Apr 27, 1983
ENA TEST KIT SM & RNP AUTO ANTIBODY
K831036
Calbiochem-Behring Corp.
Immunology · 27d