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..

181
Total
181
Cleared
109d
Avg days
1981
Since
181 devices
73–96 of 181
Cleared Dec 15, 1992
QUANTA LITE(TM) SCL-70 ELISA
K924898
Inova Diagnostics, Inc.
Immunology · 78d
Cleared Sep 18, 1992
QUANTA LITE ENA ELISA
K922829
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SS-A ELISA
K922830
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SM ELISA
K922831
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SS-B ELISA
K922832
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE RNP ELISA
K922833
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Apr 07, 1992
HEMAGEN ENA [JO-1] KIT (EIA METHOD)
K915420
Hemagen Diagnostics, Inc.
Immunology · 127d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST [SS-A (RO)]
K920383
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANIT-ENA ANTIBODY TEST [SS-B (LA)]
K920384
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST (SM)
K920385
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST KIT
K920386
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Feb 12, 1992
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K915282
Hemagen Diagnostics, Inc.
Immunology · 79d
Cleared Dec 20, 1991
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K915058
Hemagen Diagnostics, Inc.
Immunology · 42d
Cleared Dec 20, 1991
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)
K915234
Hemagen Diagnostics, Inc.
Immunology · 28d
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 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