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
49–72 of 182
Cleared Jun 15, 1998
SERAQUEST ANTI-SSB
K980639
Quest Intl., Inc.
Immunology · 116d
Cleared Apr 23, 1998
DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM
K980759
Diamedix Corp.
Immunology · 55d
Cleared Apr 08, 1997
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
K964787
Mardx Diagnostics, Inc.
Immunology · 130d
Cleared Apr 08, 1997
IS-ANTI-SSA TEST SYSTEM
K970218
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SM TEST SYSTEM
K970220
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-JO-1 TEST SYSTEM
K970228
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SSB TEST SYSTEM (720-260)
K970237
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SM/RNP (720-270)
K970238
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SCL-70 TEST SYSTEM (720-280)
K970239
Diamedix Corp.
Immunology · 77d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
K962578
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
K962719
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
K962720
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
K962722
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
K962727
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
K962728
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
K962731
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Sep 13, 1996
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
K963275
Immuno Concepts, Inc.
Immunology · 24d
Cleared Jul 10, 1996
QUANTA LITE ENA 6 ELISA
K961913
Inova Diagnostics, Inc.
Immunology · 54d
Cleared Apr 19, 1996
RELSIA SCL-70 ANTIBODY TEST SYSTEM
K955602
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
K955603
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELISA SM/RNP ANTIBODY TEST SYSTEM
K955604
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELISA JO-1 ANTIBODY TEST SYSTEM
K955605
Immuno Concepts, Inc.
Immunology · 133d
Cleared Mar 20, 1996
HYTEC AUTOIMMUNE KITS (SCL-70)
K954894
Hycor Biomedical, Inc.
Immunology · 183d
Cleared Mar 20, 1996
HYTEC AUTOIMMUNE KIT (JO-1)
K954895
Hycor Biomedical, Inc.
Immunology · 147d