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
73–96 of 182
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
Cleared Mar 20, 1996
ORGENTEC ENASCREEN PIN IMMUNO ASSAY
K955133
Orgentec
Immunology · 132d
Cleared Mar 20, 1996
ORGENTEC ENASCREEN ELISA ASSAY
K955134
Orgentec
Immunology · 132d
Cleared Dec 26, 1995
HYTEC AUTOMMUNE KIT (ENA)
K954890
Hycor Biomedical, Inc.
Immunology · 62d
Cleared Aug 24, 1995
ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT
K952253
Helix Diagnostics, Inc.
Immunology · 101d
Cleared Jun 05, 1995
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K952076
Hemagen Diagnostics, Inc.
Immunology · 33d
Cleared Jun 05, 1995
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
K952077
Hemagen Diagnostics, Inc.
Immunology · 33d
Cleared Mar 29, 1995
HEMAGEN ENA SM/RMP KIT (EIA METHOD)
K950414
Hemagen Diagnostics, Inc.
Immunology · 57d
Cleared Feb 22, 1995
HEMAGEN ENA SS-B KIT (EIA METHOD)
K946120
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SS-A KIT (EIA METHOD)
K946121
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K946122
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SM KIT (EIA METHOD)
K946123
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA JO-1 KIT (EIA METHOD)
K946124
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Dec 02, 1994
ANTI DS-DNA
K943291
Sigma Diagnostics, Inc.
Immunology · 147d
Cleared Nov 21, 1994
DIASTAT ENA SINGLE WELL SCREEN KIT
K944505
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Oct 25, 1994
QUANTA LITE ENA 5 ELISA KIT
K943076
Inova Diagnostics, Inc.
Immunology · 119d
Cleared Jul 28, 1994
ANA SCREEN ELISA TEST SYSTEM
K940362
Zeus Scientific, Inc.
Immunology · 183d
Cleared Jun 02, 1994
ENA EIA TEST KIT
K935413
David A. Fuccillo, Ph.D.
Immunology · 205d