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 Diamedix Corp..

182
Total
182
Cleared
110d
Avg days
1981
Since
182 devices
121–144 of 182
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 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 Nov 25, 1987
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
K873708
Whittaker Bioproducts, Inc.
Immunology · 71d
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